Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence

BioDrugs

Volumn 30, Issue 6, 2016, Pages 489-523

  Jacobs, Ira ^a   Petersel, Danielle ^a   Shane, Lesley G ^a   Ng, Chee Keng ^a   Kirchhoff, Carol ^a   Finch, Gregory ^a   Lula, Sadiq ^b  

^a PFIZER INC   (United States)

^b UNITED BIOSOURCE CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ABCIXIMAB; ABP 215; ADALIMUMAB; BEVACIZUMAB; BIOSIMILAR AGENT; CTP 13; ETANERCEPT; GP 2015; HYBRID PROTEIN; INFLIXIMAB; MONOCLONAL ANTIBODY; OMALIZUMAB; RANIBIZUMAB; RITUXIMAB; SB 2; TRASTUZUMAB; UNCLASSIFIED DRUG;

CHRONIC INFLAMMATION; DRUG INFORMATION; DRUG RESEARCH; HUMAN; ONCOLOGY; PRIORITY JOURNAL; PUBLICATION; REVIEW; SYSTEMATIC REVIEW; CHRONIC DISEASE; INFLAMMATION; NEOPLASMS; STATISTICS AND NUMERICAL DATA; TRENDS;

ANTIBODIES, MONOCLONAL; BIOSIMILAR PHARMACEUTICALS; CHRONIC DISEASE; HUMANS; INFLAMMATION; NEOPLASMS; RECOMBINANT FUSION PROTEINS; RITUXIMAB; SERIAL PUBLICATIONS;

EID: 84994357159     PISSN: 11738804     EISSN: 1179190X     Source Type: Journal    
DOI: 10.1007/s40259-016-0199-9     Document Type: Review

References (335)

1. Olech E. Biosimilars: rationale and current regulatory landscape. Semin Arthritis Rheum. 2016;45(5 suppl):S1–10.
2. Tsuruta LR, Lopes dos Santos M, Moro AM. Biosimilars advancements: moving on to the future. Biotechnol Prog. 2015;31(5):1139–49.
3. Sackman J, Kuchenreuther M. The bullish outlook for biosimilars. BioPharm Int 2015;28(2):1–3.
4. Pen A, Klein AV, Wang J. Health Canada’s perspective on the clinical development of biosimilars and related scientific and regulatory challenges. GaBI J. 2015;4(1):36–41.
5. IMS Institute for Healthcare Informatics. Delivering on the potential of biosimilar medicines: the role of functioning competitive markets. 2016 March 2016. Available from: http://www.imshealth.com/files/web/IMSH%20Institute/Healthcare%20Briefs/Documents/IMS_Institute_Biosimilar_Brief_March_2016.pdf. Accessed 2016 Jun 21.
6. Dorner T, Strand V, Cornes P, Goncalves J, Gulacsi L, Kay J, et al. The changing landscape of biosimilars in rheumatology. Ann Rheum Dis. 2016;74(6):974–82.
7. Krishnan A, Mody R, Malhotra H. Global regulatory landscape of biosimilars: emerging and established market perspectives. Biosimilars. 2015;5:19–32.
8. Generics and Biosimilars Initiative (GaBi). Biosimilars applications under review by EMA – December 2015. 29 Jan 2016. Available from: http://www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-December-2015. Accessed 2016 Jun 22.
9. European Medicines Agency. European Medicines Agency recommends approval of first two monoclonal-antibody biosimilars [press release]. 25 Jun 2013. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/06/news_detail_001837.jsp&mid=WC0b01ac058004d5c1. Accessed 2016 Jun 21.
10. ®. 30 May 2016. Available from: http://www.businesswire.com/news/home/20160529005047/en/. Accessed 2016 Jun 21.
11. ®, approved in the European Union [news report]. 16 Jan 2016. Available from: http://www.businesswire.com/news/home/20160116005011/en/BENEPALI%C2%AE-Etanercept-Biosimilar-Referencing-Enbrel%C2%AE-Approved-European. Accessed 2016 Jun 21.
12. Amgen. Amgen’s first biosimilar marketing authorization application submitted to European Medicines Agency for ABP 501 [news release] 4 Dec 2015. Available from: http://www.prnewswire.com/news-releases/amgens-first-biosimilar-marketing-authorization-application-submitted-to-european-medicines-agency-for-abp-501-300187922.html. Accessed 2016 Jun 21.
13. Samsung Bioepis. Samsung Bioepis submits marketing authorization application for SB2, A Remicade (infliximab) biosimilar candidate, to the European Medicines Agency [news release]. 13 May 2015. Available from: http://www.prnewswire.com/news-releases/samsung-bioepis-submits-marketing-authorization-application-for-sb2-a-remicade-infliximab-biosimilar-candidate-to-the-european-medicines-agency-300048841.html. Accessed 2016 Jun 21.
14. European Medicines Agency. EMA accepts application for etanercept biosimilar [news release]. 15 Jan 2016. Available from: http://www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-etanercept-biosimilar. Accessed 2016 Jun 21.
15. Gaffney A. After three-year delay, FDA finalizes guidance documents on biosimilarity. 28 April 2015. Available from: http://www.raps.org/Regulatory-Focus/News/2015/04/28/22058/After-Three-Year-Delay-FDA-Finalizes-Guidance-Documents-on-Biosimilarity/. Accessed 2016 Jun 21.
16. US Food and Drug Administration. FDA releases draft guidance for industry: “Labeling for biosimilar products”. 1 Apr 2016. Available from: http://www.pharmoutsourcing.com/1315-News/184872-FDA-Releases-Draft-Guidance-for-Industry-Labeling-for-Biosimilar-Products/?catid=6261. Accessed 2016 Jun 21.
17. Christl L. From our perspective: biosimilar product labeling. 15 June 2016. Available from: http://www.fda.gov/Drugs/NewsEvents/ucm493240.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed 2016 Jun 21.
18. US Food and Drug Administration. FDA approves Inflectra, a biosimilar to Remicade [news release]. 5 Apr 2016. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm. Accessed 2016 Jun 21.
19. US Food and Drug Administration. FDA Arthritis Advisory Committee recommends CTP 13 (infliximab biosimilar) for all indications of the reference product - Hospira/Pfizer [news release]. 11 Feb 2016. Available from: http://www.epgonline.org/news/fda-arthritis-advisory-committee-recommends-ctp-13-infliximab-biosimilar.cfm. Accessed 2016 Jun 21.
20. Novartis. FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept. 2016. Available from: https://www.novartis.com/news/media-releases/fda-accepts-sandoz-regulatory-submission-proposed-biosimilar-etanercept. Accessed 2016 Jun 19.
21. Barber J. FDA advisory panel backs Amgen’s proposed biosimilar of AbbVie’s Humira. 12 July 2016. Available from: http://www.firstwordpharma.com/node/1399106#axzz4EO2ytw2T. Accessed 2016 Jul 19.
22. Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Narayanan G, et al. Biosimilars-why terminology matters. Nat Biotechnol. 2011;29(8):690–3.
23. Wadhwa M, Thorpe M. Terminology for biosimilars–a confusing minefield. GaBI J. 2012;1(3–4):132–4.
24. Mysler E, Pineda C, Horiuchi T, Singh E, Mahgoub E, Coindreau J, et al. Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology. Rheumatol Int. 2016;36(5):613–25.
25. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. J Clin Epidemiol. 2009;62(10):1006–12.
26. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol. 2009;62(10):e1–34.
27. National Institute for Health Care Excellence. Single technology appraisal: user guide for company evidence submission template. Jan 2015. Available from: http://www.nice.org.uk/article/pmg24. Accessed 2016 Jun 21.
28. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17(1):1–12.
29. Downs SH, Black N. The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions. J Epidemiol Community Health. 1998;52(6):377–84.
30. Hooijmans CR, Rovers MM, de Vries RB, Leenaars M, Ritskes-Hoitinga M, Langendam MW. SYRCLE’s risk of bias tool for animal studies. BMC Med Res Methodol. 2014;14:43.
31. Drummond MF, Jefferson TO. Guidelines for authors and peer reviewers of economic submissions to the BMJ. The BMJ Economic Evaluation Working Party. BMJ. 1996;313(7052):275–83.
32. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339:b2535.
33. Shamseer L, Moher D, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015;349:g7647.
34. Wisman LAB, De Cock EPM, Reijers JAA, Kamerling IMC, Van Os SHG, de Kam ML, et al. A phase I dose-escalation and bioequivalence study of a trastuzumab biosimilar in healthy male volunteers. Clin Drug Investig. 2014;34(12):887–94.
35. Yin D, Barker KB, Li R, Meng X, Reich SD, Ricart AD, et al. A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS B327-01). Br J Clin Pharmacol. 2014;78(6):1281–90.
36. Roy PS, John S, Karankal S, Kannan S, Pawaskar P, Gawande J, et al. Comparison of the efficacy and safety of Rituximab (Mabthera™) and its biosimilar (Reditux™) in diffuse large B-cell lymphoma patients treated with chemo-immunotherapy: a retrospective analysis. Indian J Med Paediatr Oncol. 2013;34(4):292.
37. Thakral P, Singla S, Yadav MP, Vasisht A, Sharma A, Gupta SK, et al. An approach for conjugation of 177Lu-DOTA-SCN-rituximab (BioSim) & its evaluation for radioimmunotherapy of relapsed & refractory B-cell non Hodgkins lymphoma patients. Indian J Med Res. 2014;139(4):544.
38. Alexeev S, Zaritskey A, Volodicheva E, Loginov A, Orlova R, Dvornichenko V, et al. Clinical comparability of BCD-020 to innovator rituximab in patients with indolent non-Hodgkin’s lymphoma. Haematologica. 2014;99:144–5.
39. Aliaga L, Fernandez I, Sanchez M, Saavedra H, Espinoza C. Pharmacovigilance of anti CD 20 monoclonal antibody biosimilar at the Edgardo Rebagliati Martins Hospital-Peru. Drug Saf. 2013;36:925.
40. Filon O, Orlov SV, Burdaeva ON, Kopp MlV, Kotiv BN, Alekseev S, et al. Efficacy and safety of BCD-021, bevacizumab biosimilar candidate, compared to Avastin: results of international multicenter randomized double blind phase III study in patients with advanced non-squamous NSCLC [abstract 8057]. 2015 American Society of Clinical Oncology (ASCO) Annual Meeting; 2015 29 May–2 June 2015; Chicago, IL: J Clin Oncol. 2015;33(suppl; abstr 8057). http://meetinglibrary.asco.org/content/152128-156.
41. Florez A, Di Matteo T, Fresnillo G, Tudela C, Seigelchifer M, Corley E, et al. Clinical pharmacokinetic (PK) and safety (immunogenicity) of rituximab biosimilar RTXM83 in combination with chemotherapy CHOP in patients with diffuse large B-cell lymphoma (DLBCL). Blood. 2014;124(21):5472.
42. Im Y, Krasnozhon D, Bondarenko I, Zvirbule Z, Jung K, Oliynychenko P, et al. Phase I/IIb clinical trial comparing PK and safety of trastuzumab and its biosimilar candidate CT-P6 [abstract S108]. 2013. S108-S]. Available from: http://www.biosimilarz.com/wp-content/uploads/2013/03/ct-p06-in-mbc_abstract_st-gallen-2013_13mar2013.pdf. Accessed 2016 Jun 22.
43. Im Y, Odarchenko P, Grecea D, Komov D, Anatoliy CV, Gupta S, et al. Double-blind, randomized, parallel group, phase III study to demonstrate equivalent efficacy and comparable safety of CT-P6 and trastuzumab, both in combination with paclitaxel, in patients with metastatic breast cancer (MBC) as first-line treatment. J Clin Oncol. 2013;31:629.
44. Kim SJ, Kim WS, Kang HJ, Kim JS, Choi CW, Lee SI, et al. Safety, pharmacokinetic/pharmacodynamic profiles and efficacy of sait101, a biosimilar of rituximab in patients with diffuse large b-cell lymphoma. Haematologica. 2012;97 S317-S8.
45. Markus R, Kaur PP, Chow V, Zhang N, Born TL, Huynh Q, et al. Results of functional testing and pharmacokinetics comparing ABP 215 to bevacizumab [abstract no. 711]. J Clin Oncol. 2015;33.
46. ®—experience from a tertiary cancer centre in Western India. Blood. 2014;124(21):2246.
47. Orlov SV, Burdaeva ON, Nachaeva MP, Kopp MV, Kotiv BN, Sheveleva LP, et al. Pharmacokinetics and safety of BCD-021, bevacizumab biosimilar candidate, compared to Amastin in patients [abstract no. e13500]. J Clin Oncol. 2014;32.
48. Stenina MB, Ignatova E, Frolova MA, Burdaeva ON, Nechaeva MP, Kopp MV, et al. Pharmacokinetics and safety of BCD-022, trastuzumab biosimilar candidate, compared to Herceptin in patients [abstract e11576]. J Clin Oncol. 2014;32 Suppl.
49. da Silva A, Kronthaler U, Koppenburg V, Fink M, Meyer I, Papandrikopoulou A, et al. Target-directed development and preclinical characterization of the proposed biosimilar rituximab GP2013. Leuk Lymphoma. 2014;55(7):1609–17.
50. ®). BioDrugs. 2014;28(5):451–9.
51. ®). Toxicol Pathol. 2014;42(7):1069–81.
52. Choe J-Y, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, Baranauskaite A, et al. A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. doi:10.1136/annrheumdis-2015-207764.
53. Emery P, Vencovský J, Sylwestrzak A, Leszczyński P, Porawska W, Baranauskaite A, et al. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. doi:10.1136/annrheumdis-2015-207588.
54. Gu NY, Yi SJ, Kim T-E, Kim JW, Shin S-G, Jang I-J, et al. Comparative pharmacokinetics and tolerability of branded etanercept (25 mg) and its biosimilar (25 mg): a randomized, open-label, single-dose, two-sequence, crossover study in healthy Korean male volunteers. Clin Ther. 2011;33(12):2029–37.
55. Jani RH, Gupta RV, Bhatia G, Rathi G, P. AK, Sharma R, et al. A prospective, randomized, double‐blind, multicentre, parallel‐group, active controlled study to compare efficacy and safety of biosimilar adalimumab (Exemptia; ZRC-3197) and adalimumab (Humira) in patients with rheumatoid arthritis. Int J Rheum Dis (Epub 14 Jul 2015).
56. Park W, Jaworski J, Brzezicki J, Gnylorybov A, Kadinov V, Goecke Sariego I, et al. A randomised, double-blind, parallel-group, phase 1 study comparing the pharmacokinetics, safety and efficacy of CT-P13 and infliximab in patients with active ankylosing spondylitis: 54 week results from the PLANETAS study. Ann Rheum Dis. 2013;72:A516–7.
57. ®). BioDrugs. 2012;26(3):177–84.
58. Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72(10):1613–20.
59. Farkas K, Rutka M, Bálint A, Nagy F, Bor R, Milassin Á, et al. Efficacy of the new infliximab biosimilar CT-P13 induction therapy in Crohn’s disease and ulcerative colitis–experiences from a single center. Expert Opin Biol Ther. 2015;15(9):1257–62.
60. Jung YS, Park DI, Kim YH, Lee JH, Seo PJ, Cheon JH, et al. Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: a retrospective multicenter study. J Gastroenterol Hepatol. 2015;30(12):1705–12.
61. Kang Y-S, Moon HH, Lee SE, Lim YJ, Kang HW. Clinical experience of the use of CT-P13, a biosimilar to infliximab in patients with inflammatory bowel disease: a case series. Dig Dis Sci. 2015;60(4):951–6.
62. Roshique KK, Ravindran V. Efficacy and safety of a biosimilar rituximab in biologic naive patients with active rheumatoid arthritis. Clin Rheumatol. 2015;34(7):1289–92.
63. ®) in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy (24-week results). Ann Rheum Dis. 2015;74:467–8.
64. Bae S-C, Kim J, Choe J-Y, Park W, Lee SR, Ahn Y, et al. A randomized, double-blind, Phase 3 equivalence trial comparing the etanercept biosimilar, HD203, with etanercept (Enbrel (R)), in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA). Ann Rheum Dis. 2014;73:63–4. doi:10.1136/annrheumdis-2014-eular.3558.
65. Bandyopadhyay S. Safety and efficacy of rituximab-biosimilar for the treatment of moderate to severe rheumatoid arthritis patients following the failure of disease-modifying drugs: a case series from Apollo Gleneagles Hospital, Kolkata. Indian Rheumatology Association 29th Annual Conference (IRACON 2013); 2013 6–8 December 2013; Kolkota, Calcutta, India; 2013, pp. S4–5.
66. Barile-Fabris LA, Irazoque-Palazuelos F, Hernandez Vasquez R, Carrillo Vazquez S, Guzman R. Incidence of adverse events in patients treated with intended copies of biologic therapeutic agents in Colombia and Mexico. Arthritis Rheum. 2014;66:S662. doi:10.1007/s10067-014-2841-6.
67. Becker J-CP, Yin D, Melia LA, Li R, Gumbiner B, Thomas D, et al. A Phase I trial comparing PF-05280586 (a potential biosimilar) and rituximab in subjects with active rheumatoid arthritis. Arthritis Rheum. 2014;66:S660-S1.
68. Codreanu C, Mogosan C, Enache L, Stanciu D, Ionescu R, Opris D, et al. Romanian Registry of rheumatic diseases: efficacy and safety of biologic therapy in rheumatoid arthritis. Ann Rheum Dis. 2015;74:458.
69. Chung H, Ahn L, Choi Y, Shin S, Jang I, Yu K, et al. LBEC0101, an etanercept biosimilar, showed comparable tolerability and pharmacokinetic profiles to those of etanercept in healthy male volunteers. Clin Pharmacol Ther. 2014;95:S38. doi:10.1038/clpt.2013.247.
70. Gecse K, Farkas K, Lovász B, Banai J, Bene L, Gasztonyi B, et al. Biosimilar Infliximab in inflammatory bowel diseases: first interim results from a prospective nationwide observational cohort. Z Gastroenterol. 2015;53(05):A11.
71. Kaur P, Chow V, Zhang N, Moxness M, Markus R. A randomized, single-blind, single-dose, three-arm, parallel group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab: Results of comparison with adalimumab (EU). Ann Rheum Dis. 2014;73:479.
72. Kay J, Chopra A, Chandrashekara S, Olakkengil DJ, Bhojani KS, Bhatia G, et al. A phase 3, randomized, double-blind, active comparator study of the efficacy and safety of BOW015, a biosimilar infliximab, in patients with active rheumatoid arthritis on stable methotrexate doses. Ann Rheum Dis. 2014;73:64.
73. Kierkus J. Preliminary assessment of efficacy and safety of switching between originator and biosimilar infliximab in paediatric Crohn disease patients. Gastroenterology. 2015;148(4 Suppl 1):S782–3.
74. ®) in healthy male subjects. Ann Rheum Dis. 2015;74(Suppl 2):718. doi:10.1136/annrheumdis-2015-eular.2671.
75. ® (etanercept) associated with methotrexate in patients with modeate and severe rheumatoid arthritis. Ann Rheum Dis. 2013;72:A234-A.
76. Molnar T, Farkas K, Rutka M, Balint A, Nagy F, Bor R, et al. Efficacy of the new infliximab biomarker CT-P13 induction therapy on mucosal healing in ulcerative colitis patients. J Crohns Colitis. 2015;9 Suppl 1:S382. doi:10.1093/ecco-jcc/jju027.721.
77. Murphy C, Sugrue K, Mohamad G, McCarthy J, Buckley M. Biosimilar but not the same. J Crohns Colitis. 2015;9(Suppl 1):S331–2.
78. ®) in healthy subjects. Ann Rheum Dis. 2015;74:703.
79. Santos-Moreno P, Saavedra-Martinez G, Villarreal L, Gomez D, Bello-Gualtero J, Giraldo V, et al. Etanar—A etanercept biosimilar is as effective as adalimumab and infliximab in a cohort of real-life of patients with rheumatoid arthritis. Ann Rheum Dis. 2015;74:789–90.
80. ®) in healthy subjects. Ann Rheum Dis. 2015;74:459–60.
81. Udata C, Hua SY, Yin D, Salts S, Meng X, Rehman MI. A Phase I pharmacokinetics trial comparing PF-06438179 (a potential biosimilar) and infliximab in healthy volunteers (REFLEXTIONS B537-01). Ann Rheum Dis. 2014;73:494.
82. Yoo DH, Park W, Shim S-C, Suh C-H, Yun J, Pyo T. A randomized, double-blind, three-arm, parallel group, single-dose study to compare the pharmacokinetics, safety, and tolerability of three formulations of infliximab (CT-P13, EU-sourced infliximab and US-sourced infliximab) in healthy volunteers. Arthritis Rheum. 2014;66(Suppl):1509.
83. Yoo DH, Park W, Jeka S, Cons Molina F, Hrycaj P, Wiland P, et al. Impact of anti-drug antibody on efficacy and safety over week 24 in both CT-P10 and innovator rituximab treatment groups. Arthritis Rheum. 2014;65(Suppl 10):S736.
84. Maity S, Ullanat R, Lahiri S, Shekar S, Sodhan G, Vyas A, et al. A non-innovator version of etanercept for treatment of arthritis. Biologicals. 2011;39(6):384–95.
85. Brodszky V, Baji P, Balogh O, Péntek M. Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries. Eur J Health Econ. 2014;15(1):65–71.
86. ®) for the treatment of autoimmune diseases in five European countries. Adv Ther. 2015;32(8):742–56.
87. Wu B, Song Y, Leng L, Bucala R, Lu LJ. Treatment of moderate rheumatoid arthritis with different strategies in a health resource-limited setting: a cost-effectiveness analysis in the era of biosimilars. Clin Exp Rheumatol. 2015;33(1):20–6.
88. Choi DH, Suh JW, Park KW, Kang HJ, Kim HS. Assessment of the bioequivalence of brand and biogeneric formulations of abciximab for the treatment of acute coronary syndrome: a prospective, open-label, randomized, controlled study in Korean patients. Clin Ther. 2009;31(8):1804–11.
89. Zhou B, Lin B, Li J, Qian W, Hou S, Zhang D, et al. Tolerability, pharmacokinetics and pharmacodynamics of CMAB007, a humanized anti-immunoglobulin E monoclonal antibody, in healthy Chinese subjects. MAbs. 2012;4(1):110–9.
90. Flores-Ortiz LF, Campos-García VR, Perdomo-Abúndez FC, Pérez NO, Medina-Rivero E. Physicochemical properties of rituximab. J Liq Chromatogr Relat Technol. 2014;37(10):1438–52.
91. Griffiths E, Thorpe R, Wadhwa M, Yeowon S. Evaluation of similar biotherapeutic products: scientific and regulatory challenges. Biologicals. 2011;39(5):249–358.
92. North American Center for Continuing Medical Education. CME survey: biosimilars. 24 May 2013. Available from: http://www.naccme.com/sites/naccme.com/files/biosimilar-survey-results.pdf. Accessed 2016 Jun 21.
93. Coalition of State Rheumatology Organizations (CSRO). CSRO releases Physician Biosimilars Survey results [press release]. 26 May 2016; Available from: http://csro.info/app/document/8382846;jsessionid=P5zJOo6TwPYoXVXzwSYawvyM.undefined. Accessed 2016 Jun 21.
94. Alliance for Safe Biologic Medicines (ASBM). New ASBM survey provides physicians’ views on biosimilar labeling [news release]. Feb 2015; Available from: https://safebiologics.org/2015/03/new-asbm-survey-provides-physicians-views-on-biosimilar-labeling/. Accessed 2016 Jun 21.
95. Olson K. ASBM labeling survey. Feb 2015; Available from: http://docs.house.gov/meetings/IF/IF14/20160204/104408/HHRG-114-IF14-20160204-SD010.pdf. Accessed 2016 Jun 22.
96. US Food and Drug Administration. Labeling for biosimilar products: guidance for industry, draft guidance. March 2016. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM493439.pdf. Accessed 2016 Jun 21.
97. Macdonald JC, Hartman H, Jacobs IA. Regulatory considerations in oncologic biosimilar drug development. MAbs. 2015;7(4):653–61.
98. Hallersten A, Furst W, Mezzasalma R. Physicians prefer greater detail in the biosimilar label (SmPC). Results of a survey across seven European countries. Regul Toxicol Pharmacol. 2016;77:275–81.
99. Market Wired. Nearly half of US physicians say they will prescribe more biosimilars, according to new data from InCrowd [news release]. 3 March 2016. Available from: http://www.marketwired.com/press-release/nearly-half-us-physicians-say-they-will-prescribe-more-biosimilars-according-new-data-2102567.htm. Accessed 2016 Jun 21.
100. Azevedo VF, Galli N, Kleinfelder A, D’Ippolito J, Urbano PC. Etanercept biosimilars. Rheumatol Int. 2015;35(2):197–209.
101. Azevedo VF, Sandorff E, Siemak B, Halbert RJ. Potential regulatory and commercial environment for biosimilars in Latin America. Value Health Reg Issues. 2012;1:228–34.
102. Pitts P, Stark R. Biosimilars: the precarious struggle between cost-driven health care policy and patient-centered care. 27 Sep 2012. Available from: http://www.washingtonpolicy.org/publications/detail/biosimilars-the-precarious-struggle-between-cost-driven-health-care-policy-and-patient-centered-care. Accessed 2016 Jun 23.
103. Mellstedt H. Clinical considerations for biosimilar antibodies. EJC Suppl. 2013;11(3):1–11.
104. European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 1 July 2015. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf. Accessed 2016 Jun 21.
105. WHO Expert Committee on Biological Standards. Guidelines on evaluation of similar biotherapeutic products (SBPs). 19-23 Oct 2009. Available from: http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf. Accessed 2016 Jun 21.
106. World Health Organization. Guidelines on the quality, safety, and efficacy of biotherapeutic protein products prepared by recombinant DNA technology. 21–25 Oct 2013. Available from: http://www.who.int/biologicals/biotherapeutics/rDNA_DB_final_19_Nov_2013.pdf. Accessed 2016 Jun 21.
107. US Food and Drug Administration. Immunogenicity assessment for therapeutic protein products: guidance for industry. Aug 2014. Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm338856.pdf. Accessed 2016 Jun 21.
108. US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. April 2015. Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291128.pdf. Accessed 2016 Jun 21.
109. Zuniga L, Calvo B. Biosimilars: pharmacovigilance and risk management. Pharmacoepidemiol Drug Saf. 2010;19(7):661–9.
110. Blank T. Safety and toxicity of biosimilars—EU versus US regulation. GaBI J. 2013;2(3):144–50.
111. Zelenetz AD, Ahmed I, Braud EL, Cross JD, Davenport-Ennis N, Dickinson BD, et al. NCCN Biosimilars White Paper: regulatory, scientific, and patient safety perspectives. J Natl Compr Canc Netw. 2011;9(Suppl 4):S1–22.
112. Schneider CK, Vleminckx C, Gravanis I, Ehmann F, Trouvin JH, Weise M, et al. Setting the stage for biosimilar monoclonal antibodies. Nat Biotechnol. 2012;30(12):1179–85.
113. Dorvignit D, Palacios JL, Merino M, Hernandez T, Sosa K, Casaco A, et al. Expression and biological characterization of an anti-CD20 biosimilar candidate antibody: a case study. MAbs. 2012;4(4):488–96.
114. Kaplanov K, Zaritskiy A, Alexeev S, Volodicheva E, Loginov A, Orlova R, et al. Key results of international randomized open-label clinical study of BCD-020 (rituximab biosimilar candidate) in patients with B-cell non-Hodgkin’s lymphoma. Blood. 2014;124(21):5467. http://www.bloodjournal.org/content/124/21/5467?sso-checked=true.
115. Poddubnaya I, Babicheva L, Kaplanov K, Zaritskey A, Volodicheva E, Alexeev S, et al. Comparison of pharmacokinetics and pharmarodynamics of BCD-020 with innovator rituximab to palients with indolent non-Hodgkin lymphoma. J Clin Oncol. 2014;32(15):e19545.
116. Yoo DH, Park W, Jeka S, Molina FC, Hrycaj P, Wiland P, et al. A randomized, controlled, multicenter, 2-arm, parallel-group, double-blind study to demonstrate the equivalence of CT-P10 to innovator rituximab with respect to pharmacokinetic profile in patients with rheumatoid arthritis. Arthritis Rheum. 2013;65(Suppl 10):1736.
117. da Silva A, Kronthaler U, Meyer I, Papandrikopoulou A, Stangler T, Visser JM. Target-directed development of a proposed biosimilar rituximab (GP2013): comparability of antibody-dependent cellular cytotoxicity activity and PRE-clinical pharmacokinetics and pharmacodynamics with originator rituximab. American College of Rheumatology/Association of Rheumatology Health Professionals Annual Scientific Meeting; 9–14 November 2012; Washington DC; 2012: S911.
118. da Silva A, Kronthaler U, Meyer I, Fritsch C, Schneiderer T, Stangler T, et al. Physicochemical, functional, and pharmacologic comparability between the proposed biosimilar rituximab GP2013 and originator rituximab as the foundation for biosimilarity. J Clin Oncol. 2013;31(suppl; abstr 3075). http://meetinglibrary.asco.org/content/116796-132.
119. Visser JM, Feuerstein I, Stangler T, Schmiederer T, Fritsch C, Schiestl M. Physicochemical and functional comparability between the proposed biosimilar rituximab GP2013 and originator rituximab. BioDrugs. 2013;27(5):495–507.
120. Hurst SI, Ryan AM, Ng C-K, Ploch SA, Finch GL, Leach MW. Nonclinical assessments demonstrating the similarity of the proposed biosimilar PF-05280586 and rituximab. Ann Rheum Dis. 2013;72:A198.
121. ®) and the potential biosimilar PF-05280586. American Association of Pharmaceutical Scientists (AAPS) National Biotechnology Conference; 20–23 May 2013; San Diego, CA; 2013: M1125.
122. Karnik S, Thompson M, De Gruttola H, Ferrari S, Gu L, Aggarwal P, et al. Characterization and comparison of PF-05280586—A proposed rituximab biosimilar to the licensed product American Association of Pharmaceutical Scientists (AAPS) National Biotechnology Conference; 2013 20–23 May 2013; San Diego, CA; 2013: M1038.
123. Jacobs I, Yin D, Melia LA, Gumbiner B, Suster M, Thomas D, et al. A phase I trial comparing PF-05280586 (a potential biosimilar) and rituximab in patients with active rheumatoid arthritis. Ann Rheum Dis. 2015;74:724.
124. ®) and rituximab-Pfizer in cynomolgus monkeys. 52nd Annual Meeting and ToxExpo of the Society of Toxicology (SOT) 10–14 March 2013; San Antonio, TX; 2013:382.
125. Thomas D, Becker J-CP, Ng C-K. Comparison of proposed biosimilar PF-05280586 with rituximab: nonclinical and Phase I clinical assessments. Arthritis Rheum. 2013;65:S1014-S.
126. Williams J, Hutmacher MH, Zierhut M, Becker J, Gumbiner B, Spencer-Green G, et al. Assessment of clinical response in patients with rheumatic arthritis (RA) between PF-05280586, a proposed biosimilar to rituximab and two rituximab products. Clin Pharmacol Ther. 2015;97(S1):S96. doi:10.1002/cpt.52.
127. Yin D, Becker J-C, Melia L, Li R, Gumbiner B, Thomas D, et al. A Phase I pharmacokinetics trial comparing PF-05280586 (a potential biosimilar) and rituximab in subjects with active rheumatoid arthritis with active disease in TNF failures (REFLECTIONS B328-01). Ann Rheum Dis. 2014;73:497.
128. Seigelchifer M, Corley E, Fresnillo G, Pesce A, Bes C, Elise M, et al. Development of RTXM83 (a potential rituximab biosimilar): In vitro and in vivo comparability with MabThera [Abstract no. e14020]. J Clin Oncol. 2014;32 Suppl.
129. Kumar V, Vemuri S, Lella RK, Babu MN, Atluri A, Gowravaram M, et al. Suitability of ‘one assay’ for immunogenicity assessment of both proposed biosimilar and innovator rituximab. American Association of Pharmaceutical Scientists National Biotechnology Conference; 2014 2–4 November 2014; San Diego, CA; 2014: M1042.
130. Lin S, Ramatlapeng D, Hanning J, Bakewell W. Comparability study of monoclonal biosimilar drug products using various analytical methods. CASS WCBP; 2014; Washington DC; 2014: 104.
131. Mekhssian K, Mess JN, Montalibet J, Garofolo F. Application of complementary HRMS methodologies for a thorough biosimilar comparability assessment. American Association of Pharmaceutical Scientists (AAPS) National Biotechnology Conference; 2015 8-10 June 2015; San Francisco, CA; 2015: T2055.
132. Roy PS, John S, Kannan S, Gujral S, Gawande J, B. B, et al. Comparison of efficacy and safety of rituximab (Mabthera) and its biosimilar (Reditux) in diffuse large b cell lymphoma (DLBCL) patients treated with chemo-immunotherapy: a retrospective analysis. 53rd National Conference of Indian Society of Hematology and Blood Transfusion (ISHBT) 2012 9-11 November 2012; Puri, India: Springer; 2012: Abstract no. 234.
133. Roy PS, Sengar M, Menon H, et al. A retrospective single centre analysis of safety, toxicity and efficacy of rituximab (original) and its biosimilar in diffuse large B-cell lymphoma patients treated with chemo-immunotherapy. European Society for Medical Oncology (ESMO) Congress; 2012 28 September–02 October 2012; Vienna, Austria; 2012; Abstract no. ix351.
134. Bandyopadhyay S. Efficacy and safety of rituximab-biosimilar in rheumatoid arthritis. 16th Asia Pacific League of Associations for Rheumatology (APLAR) Congress; 31 March-4 April 2014; Cebu City, Philippines; 2014:57.
135. Born TL, Huynh Q, Mathur A, Velayudhan J, Canon J, Reynhardt K, et al. Funtional similarity assessment results comparing bevacizumab to biosimilar candidate ABP 215. Ann Oncol. 2014;25(Suppl 4):iv163–iv.
136. Hutterer K, Liu J, Martinez T, Pace D, Yates Z, Velayudhan J, et al. Analytical similarity assessment of a biosimilar to bevacizumab. WCBP Symposium of CASS; 2015 27 Jan 2015; Washington DC; 2015: 146
137. Markus RA, Born T, Chow V, Zhang N, Huynh Q, Maher G, et al. Functional similarity and human pharmacokinetic (PK) equivalence of ABP 215 and bevacizumab [Abstract no. e14659]. J Clin Oncol. 2015;33.
138. ClinicalTrials.gov. Efficacy and safety study of ABP 215 compared with bevacizumab in subjects with advanced non-small cell lung cancer. 28 April 2016. Available from: https://clinicaltrials.gov/show/NCT01966003. Accessed 2016 Jun 21.
139. ClinicalTrials.gov. A safety and efficacy study of BCD-021 with paclitaxel and carboplatin compared to Avastin with paclitaxel and carboplatin in non-small cell lung cancer. 2 Feb 2015. Available from: https://clinicaltrials.gov/show/NCT01763645. Accessed 2016 Jun 21.
140. ® in patients with neovascular wet age-related macular degeneration (GALATIR). 30 March 2016. Available from: https://clinicaltrials.gov/show/NCT02036723. Accessed 2016 Jun 21.
141. ®) in first-line treatment mCRC patients. 19 March 2016. Available from: https://clinicaltrials.gov/show/NCT02069704. Accessed 2016 Jun 21.
142. Grunder B. Characterization and similarity assessment of bevacizumab and a proposed biosimilar. 2014 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition; 2–6 November 2014; San Diego, CA; 2014: W5349.
143. Peraza M, Shiue M, Phenix S, Rule K, Finch GL, Thibault S, et al. Comparative nonclinical assessment of the potential biosimilar PF-06439535 and bevacizumab. 54th Annual Meeting of Society of Toxicology (SOT) 2015 22–26 March 2015; San Diego, CA; 2015: Abstract no. 129.
144. ClinicalTrials.gov. A pharmacokinetic study comparing PF-06439535 and bevacizumab In healthy male volunteers (REFLECTIONS B739-01). 14 Aug 2014. Available from: https://clinicaltrials.gov/show/NCT02031991. Accessed 2016 Jun 21.
145. ClinicalTrials.gov. A comparative study of PF-06439535 plus paclitaxel-carboplatin and bevacizumab plus paclitaxel-carboplatin patients with advanced non-squamous NSCLC. 14 June 2015. Available from: https://clinicaltrials.gov/show/NCT02364999. Accessed 2016 Jun 21.
146. Archuadze S, Shipaeva P, Dwivedi Y, Lavrovsky M, Samsonov M, Oshodi T. Pharmacokinetic profile of RPH-001, a recombinant humanized monoclonal antibody to human VEGF following administration by intravenous infusion in the cynomolgus monkey. Toxicologist. 2015;144(1):128.
147. ClinicalTrials.gov. Pharmacokinetic, safety, tolerability, and immunogenicity study of SB8 in healthy male subjects. 24 Nov 2015. Available from: https://clinicaltrials.gov/show/NCT02453672. Accessed 2016 Jun 21.
148. ClinicalTrials.gov. A safety and efficacy study of BCD-022 with paclitaxel compared to Herceptin with paclitaxel in HER2-positive metastatic breast cancer patients. 2 Feb 2015. Available from: https://clinicaltrials.gov/show/NCT01764022. Accessed 2016 Jun 21.
149. ClinicalTrials.gov. Demonstrate efficacy and safety of metastatic breast cancer (Compare). 11 Feb 2015. Available from: https://clinicaltrials.gov/show/NCT01084876. Accessed 2016 Jun 21.
150. ClinicalTrials.gov. Efficacy and safety evaluating study of CT-P6 in HER2 positive early breast cancer. 17 Dec 2015. Available from: https://clinicaltrials.gov/show/NCT02162667. Accessed 2016 Jun 21.
151. Wisman L, De Cock E, Reijers J, De Visser I, De Kam M, van Os S, et al. A phase I dose escalation and bioequivalence study of a trastuzumab biosimilar (FTMB) in healthy male volunteers. European Society for Medical Oncology (ESMO) Congress; 28 September-02 October 2012; Vienna, Austria; 2012: ix103–ix4.
152. ClinicalTrials.gov. Efficacy and safety study of ABP 980 compared with trastuzumab in subjects with HER2 positive early breast cancer (Lilac). 11 May 2016. Available from: https://clinicaltrials.gov/show/NCT01901146. Accessed 2016 Jun 21.
153. Boyle PJ, DeGruttola H, Ferrari S, Gu L, Aggarwal P, Thompson M, et al. Characterization and comparison of PF-05280014—A proposed trastuzumab biosimilar to the licensed product. American Association of Pharmaceutical Scientists (AAPS) National Biotechnology Conference; 2013 20-22 May 2013; San Diego, CA; 2013: M1037.
154. Hurst S, Ryan A, Ng C, Thompson M, McNally J, Ploch S, et al. Comparative nonclinical assessments of trastuzumab-US and trastuzumab-EU (Herceptin®) and the potential biosimilar PF-05280014 American Association of Pharmaceutical Scientists National Biotechnology Conference; 20-23 May 2013; San Diego, CA; 2013: M1124.
155. Ryan AM, Hurst S, McNally JM, Lorello LG, Finch GL, Leach MW, et al. Comparative pharmacokinetics of trastuzumab-US and trastuzumab-EU and the potential biosimilar trastuzumab-Pfizer in male CD-1 mice. Eur J Cancer. 2012;48:98.
156. Jacobs IA, Ewesuedo R, Yin D, Li R, Hurst S, Ryan AM, et al. Development of PF-05280014, a potential biosimilar to trastuzumab [abstract]. American Society of Clinical Onology (ASCO) 2015 Annual Meeting; 2015 29 May-2 June 2015; Chicago, IL; 2015:618.
157. Ricart AD, Zacharchuk C, Reich SD, Meng X, Barker KB, Taylor CT, et al. A Phase I pharmacokinetics trial comparing PF-05280014 and trastuzumab in healthy volunteers (reflections B327-01). 35th Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS); 4-8 December 2012; San Antonio, TX: Cancer Res; 2012: Abstract no. OT1105.
158. Yin D, Barker KB, Li R, Meng X, Reich SD, Ricart AD, et al. A Phase I pharmacokinetics trial comparing PF-05280014 (a potential biosimilar) and trastuzumab in healthy volunteers (REFLECTIONS B327-01). J Clin Oncol. 2013;31 Suppl: Abstract no. 171.
159. Yin D, Cai CH, Taylor CT, Zacharchuk CM, Rudin D, Reich SD, et al. Immunogenicity assessment of PF-05280014, a potential biosimilar to trastuzumab, in healthy subjects (REFLECTIONS B327-01). Eur J Cancer. 2013;49:S176–7.
160. Ewesuedo R, Barker KB, Taylor CT, Jacobs I. A Phase 3 randomized, double-blind trial comparing PF-05280014 + paclitaxel vs trastuzumab + paclitaxel for treatment of HER2 + metastatic breast cancer. Cancer Res. 2013;73(24).
161. Jacobs I, Coiro J, Hilton F, Orazem J, Abbas R, Zacharchuk C. A Phase 3 randomized, double-blind trial comparing PF-05280014 + docetaxel and carboplatin vs. trastuzumab + docetaxel and carboplatin for neoadjuvant treatment of operable HER2 + breast cancer. Cancer Res. 2015;75(9 Suppl):Abstract no. OT3-1-02-OT3-1.
162. ClinicalTrials.gov. A study evaluating the safety of PF-05280014 and trastuzumab In healthy male volunteers (REFLECTIONS B327-06). 21 April 2014. Available from: https://clinicaltrials.gov/show/NCT02015156. Accessed 2016 Jun 21.
163. ClinicalTrials.gov. Pharmacokinetic, safety, tolerability and immunogenicity study of SB3 in healthy male subjects. 19 May 2014. Available from: https://clinicaltrials.gov/show/NCT02075073. Accessed 2016 Jun 21.
164. ® in women with HER2 positive breast cancer. 2 May 2016. Available from: https://clinicaltrials.gov/show/NCT02149524. Accessed 2016 Jun 21.
165. ClinicalTrials.gov. Safety and efficacy study of BCD-020 in therapy of non-Hodgkin’s lymphoma. 12 Jan 2016. Available from: https://clinicaltrials.gov/show/NCT01701232. Accessed 2016 Jun 21.
166. ClinicalTrials.gov. Study of safety and efficacy of BCD-020 comparing to MabThera in patients with rheumatoid arthritis (BIORA). 12 Jan 2016. Available from: https://clinicaltrials.gov/show/NCT01759030. Accessed 2016 Jun 21.
167. ClinicalTrials.gov. Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis. 6 April 2016. Available from: https://www.clinicaltrials.gov/ct2/show/record/NCT01682512. Accessed 2016 Jun 21.
168. ClinicalTrials.gov. To demonstrate equivalence of pharmacokinetics and noninferiority of efficacy for CT-P10 in comparison with Rituxan (rituximab). 11 Feb 2016. Available from: https://clinicaltrials.gov/show/NCT02162771. Accessed 2016 Jun 21.
169. ClinicalTrials.gov. To compare efficacy and safety between CT-P10 and Rituxan in patients with low tumour burden follicular lymphoma. 25 April 2016. Available from: https://clinicaltrials.gov/show/NCT02260804. Accessed 2016 Jun 21.
170. ClinicalTrials.gov. PK similarity prospective phase 3 study in patients with rheumatoid arthritis (rituximab). 3 Nov 2015. Available from: https://clinicaltrials.gov/show/NCT02149121. Accessed 2016 Jun 21.
171. ClinicalTrials.gov. Long-term efficacy and safety of CT-P10 in patients with RA. 25 Nov 2015. Available from: https://clinicaltrials.gov/show/NCT01873443. Accessed 2016 Jun 21.
172. ClinicalTrials.gov. GP2013 in the treatment of RA patients refractory to or intolerant of standard therapy. 2011 4 Feb 2016. Available from: https://clinicaltrials.gov/show/NCT01274182. Accessed 2016 Jun 21.
173. ClinicalTrials.gov. GP2013 in the treatment of patients with previously untreated, advanced stage follicular lymphoma (ASSIST_FL). 15 March 2016. Available from: https://clinicaltrials.gov/show/NCT01419665. Accessed 2016 Jun 21.
174. ® (ASSIST-RT). 3 May 2016 Available from: https://clinicaltrials.gov/show/NCT02514772. Accessed 2016 Jun 21.
175. ® (rituximab-EU) for the first-line treatment of patients with CD20-positive, low tumor burden, follicular lymphoma (REFLECTIONS B328-06). 1 June 2016. Available from: https://clinicaltrials.gov/show/NCT02213263. Accessed 2016 Jun 21.
176. ClinicalTrials.gov. Study of RTXM83 plus CHOP chemotherapy versus a rituximab plus CHOP therapy in patients with non Hodgkin’s lymphoma. 19 May 2016. Available from: https://clinicaltrials.gov/show/NCT02268045. Accessed 2016 Jun 21.
177. Born T, Velayudhan J, Chen Y, Thomas H, Pastula C, Maher G, et al. Demonstration of functional similarity comparing adalimumab to biosimilar candidate ABP 501. Arthritis Rheum. 2014;66(S10):S661.
178. Born T, Velayudhan J, Mathur A, Chen YF. Demonstration of functional equivalence of proposed biosimilar ABP 501 to adalimumab. 23rd European Academy of Dermatology and Venereology (EADV) Congress; 2014 8-12 Oct 2014; Amsterdam, The Netherlands; 2014: P337.
179. Kaur P, Chow V, Zhang N, Markus R. Relationship between pharmacokinetics and anti-drug antibody status of ABP 501, a biosimilar candidate to adalimumab. Ann Rheum Dis. 2015;74:714.
180. Kaur PP, Chow V, Zhang N, Moxness M, Markus R. Pharmacokinetic equivalence of ABP 501 relative to adalimumab: results from a randomized, single-blind, single-dose, parallel group study in healthy subjects. Arthritis Rheum. 2014;66:S661–2.
181. Liu J, Hutterer K, Eris T, Abel J, Jiang Y, Li C, et al. Analytical similarity assessment of a biosimilar to adalimumab. American Association of Pharmaceutical Scientists (AAPS) Annual Meeting; 2-4 November 2014; San Diego, CA; 2014: W5350.
182. Tatarewicz S, Miller M, Zhou L, Moxness M. Biosimilar immunogenicity assessment strategy American Association of Pharmaceutical Scientists (AAPS) National Biotechnology Conference; 2-4 November 2014; San Diego, CA; 2014: Abstract no. M1069.
183. ClinicalTrials.gov. Long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis. 21 April 2016. Available from: https://clinicaltrials.gov/show/NCT02114931. Accessed 2016 Jun 21.
184. ®) in adults with moderate to severe plaque psoriasis. 19 May 2015. Available from: https://clinicaltrials.gov/show/NCT01970488. Accessed 2016 Jun 21.
185. ClinicalTrials.gov. Efficacy and safety study of ABP 501 compared to adalimumab in subjects with moderate to severe rheumatoid arthritis (RA). 14 May 2015. Available from: https://clinicaltrials.gov/show/NCT01970475. Accessed 2016 Jun 21.
186. ClinicalTrials.gov. Comparative clinical trial to evaluate pharmacokinetics, tolerance and safety of BCD-057 and Humira in healthy volunteers. 15 April 2016. Available from: https://clinicaltrials.gov/show/NCT02395055. Accessed 2016 Jun 21.
187. ClinicalTrials.gov. BI 695501 compared to adalimumab in patients with active rheumatoid arthritis. 6 June 2016. Available from: https://clinicaltrials.gov/ct2/show/record/NCT02137226. Accessed 2016 Jun 21.
188. ClinicalTrials.gov. Comparison of CHS-1420 versus Humira in subjects with chronic plaque psoriasis (PsOsim). 8 March 2016. Available from: https://clinicaltrials.gov/show/NCT02489227. Accessed 2016 Jun 21.
189. ®. Ann Rheum Dis. 2014;73(Suppl 2):943. doi:10.1136/annrheumdis-2014-eular.1545.
190. Kronthaler U, da Silva A, Poetzl J, Seliskar M, Baron M. Similar preclinical pharmacokinetics of the proposed biosimilar adalimumab GP2017 and originator adalimumab upon single and multiple administrations. J Am Acad Dermatol. 2014;70:AB190.
191. Kronthaler U, Hofmann HP, Poetzl J, Demin I, Didier R, da Silva A. Characterization of efficacy and biomarker response of the proposed adalimumab biosimilar GP2017 compared to originator adalimumab in a humanized mouse model. 23rd Congress of the European Acadamy of Dermatology and Venereology (EADV); 2014 8–12 October 2014; Amsterdam, The Netherlands; 2014: P338.
192. ClinicalTrials.gov. Study to demonstrate equivalent efficacy and to compare safety of biosimilar adalimumab (GP2017) and Humira (ADACCESS). 9 June 2016. Available from: https://clinicaltrials.gov/show/NCT02016105. Accessed 2016 Jun 21.
193. ClinicalTrials.gov. Pharmacokinetics and safety study of LBAL in healthy subjects. 12 June 2015. Available from: https://clinicaltrials.gov/ct2/show/record/NCT02206867. Accessed 2016 Jun 21.
194. Derzi M, Ripp SL, Ng C, Shoieb AM, Finch G, Lorello LG, et al. Comparative nonclinical assessments of the potential biosimilar PF-06410293 and adalimumab. 53rd Annual Meeting of the Society of Toxicology; 2014 23–27 March 2014; Phoenix, AZ; 2014:70.
195. Wang X, Zhou J, Ma Q, Buckery R, Cai CHS, Chen L. Development and validation of a cell-based neutralizing anti-adalimumab antibody detection methods for adalimumab biosimilar program. American Association of Pharmaceutical Scientists (AAPS) National Biotechnology Conference; 2–4 November 2014; San Diego, CA; Abstract no. M1023.
196. ClinicalTrials.gov. A study of PF-06410293 following subcutaneous administration using a prefilled syringe or a prefilled pen In healthy adult subjects (B538-05). 3 June 2016. Available from: https://clinicaltrials.gov/ct2/show/record/NCT02572245?term=PF-06410293&rank=1. Accessed 2016 Jun 21.
197. ClinicalTrials.gov. Study of PF-06410293 and adalimumab In healthy subjects (REFLECTIONS B538-01). 13 Feb 2014. Available from: https://clinicaltrials.gov/ct2/show/record/NCT01870986?term=PF-06410293&rank=3. Accessed 2016 Jun 21.
198. ClinicalTrials.gov. A study Of PF-06410293 (adalimumab-Pfizer) and adalimumab (Humira) In healthy subjects (REFLECTIONS B538-07) (B538-07). 10 April 2015. Available from: https://clinicaltrials.gov/ct2/show/record/NCT02237729?term=PF-06410293&rank=4. Accessed 2016 Jun 21.
199. ClinicalTrials.gov. A study Of PF-06410293 (adalimumab-Pfizer) and adalimumab (Humira) In combination with methotrexate In subjects with active rheumatoid arthritis (REFLECTIONS B538-02). 13 June 2016. Available from: https://clinicaltrials.gov/ct2/show/record/NCT02480153?term=PF-06410293&rank=2. Accessed 2016 Jun 21.
200. ClinicalTrials.gov. Pharmacokinetics, safety, and tolerability study of the pen and PFS of SB5 in healthy subjects. 14 Dec 2015. Available from: https://clinicaltrials.gov/show/NCT02326233. Accessed 2016 Jun 21.
201. ® in subjects with moderate to severe rheumatoid arthritis despite methotrexate therapy. 2 Dec 2015. Available from: https://clinicaltrials.gov/show/NCT02167139. Accessed 2016 Jun 21.
202. ClinicalTrials.gov. Comparative evaluation of pharmacokinetics and safety of BCD-055 and Remicade in patients with ankylosing spondylitis. 3 May 2016. Available from: https://clinicaltrials.gov/show/NCT02359903. Accessed 2016 Jun 21.
203. Kay J, Chopra A, Chandrashekara S, Olakkengil D, Bhojani K, Bhatia G, et al. Secondary efficacy outcomes from a Phase 3 study support clinical equivalence between BOW015 and infliximab in patients with active rheumatoid arthritis on stable methotrexate doses. Ann Rheum Dis. 2015;74(Suppl 2):1034. doi:10.1136/annrheumdis-2015-eular.4286.
204. Kay J, Chopra A, Lassen C, Shneyer L, Wyand M. BOW015, A biosimilar infliximab: Disease activity and disability outcomes from a Phase 3 active comparator study in ptients with active rheumatoid arthritis on stable methotrexate doses. Ann Rheum Dis. 2015;74:462–3.
205. Kay J, Lassen C, Trokan L, Wyand M. Safety profile of BOW015, a biosimilar infliximab, in healthy subjects and patients with active rheumatoid arthritis. Ann Rheum Dis. 2015;74:706. doi:10.1136/annrheumdis-2015-eular.4107.
206. Kay J, Wyand M, Chandrashekara S, Olakkengil DJ, Bhojani K, Bhatia G, et al. BOW015, a biosimilar infliximab, in patients with active rheumatoid arthritis on stable methotrexate doses: 54-week results of a randomized, double-blind, active comparator study. Arthritis Rheum. 2014;66:S1–S1402. http://acrabstracts.org/abstract/bow015-a-biosimilar-infliximab-in-patients-with-active-rheumatoid-arthritis-on-stable-methotrexate-doses-54-week-results-of-a-randomized-double-blind-active-comparator-study/.
207. Lambert J, Wyand M, Lassen C, Shneyer L, Thomson E, Kay J. Pharmacokinetic results from a Phase 1, single-centre, double-blind, randomised, single-dose, parallel group study comparing 5 MG/KG IV infusion of BOW015 and reference infliximab in healthy male volunteers. Ann Rheum Dis. 2015;74 Suppl 2:462.
208. Andrick B, Stroyne K, Kamal K, Meng W. Predicting immunogenicity of infliximab: Pharmacoeconomic implications for biosimilars. American Pharmacists Association (APhA) 2014 Annual Meeting and Exposition; 2014 28–31 March 2014; Orlando, FL: e185.
209. Braun J, Baraliakos X, Kudrin A, Kim H, Lee SJ. Striking discrepancy in the development of anti-drug antibodies (ADA) in patients with rheumatoid arthritis (RA) and ankylosing spondylitis (AS) in response to infliximab (INF) and its biosimilar CT-P13. Arthritis Rheum. 2014;66:3538–9.
210. Braun J, Park W, Yoo DH, Suh CH, Shim SC, Lee SJ, et al. What intrinsic and extrinsic factors affect the developement of anti-drug antibody to innovator infliximab and its biosimilar CT-P13 in rheumatoid arthritis and ankylosing spondylitis. Ann Rheum Dis. 2015;74:463–4.
211. Brodszky V, Gulacsi L, Balogh O, Baji P, Rencz F, Péntek M. Budget impact analysis of biosimilar infliximab for the treatment of Crohn’s disease in six Central Eastern European countries. Value Health. 2014;17(7):A364.
212. Jha A, Upton A, Dunlop WCN. Budget impact analysis of introducing biosimilar infliximab for the treatment of auto immune disorders in five European countries. Value Health. 2014;7(17):A525.
213. ®. MAbs. 2014;6:1163–77.
214. Kang HW, Lim YJ, Kim JH, Kang Y-S. An experience of anti-TNF biosimilar, CT-P13 use: Clinical efficacy, safety and interchangeability in inflammatory bowel disease; A pilot study. J Crohns Colitis. 2014;Suppl 1(8):S303.
215. Kim J, Hong J, Kudrin A. 5 Year budget impact analysis of biosimilar infliximab for the treatment of rheumatoid arthritis in UK, Italy, France and Germany. Arthritis Rheum. 2014;66(S10):S512.
216. Kim J, An Hong J, Kudrin A. 5 year budget impact analysis of CT-P13 (infliximab) for the treatment of Crohn’s Disease in UK, Italy and France [P137]. J Crohns Colitis. 18–21 February 2015;9(Suppl 1):S144-5.
217. McCarthy G, Bitoun CE, Guy H. Introduction of an infliximab biosimilar (CT-P13): a five-year budget impact analysis for the treatment of rheumatoid arthritis in Ireland. Value Health. 2013;7(16):A558.
218. Park W, Hrycaj P, Jeka S, Kovalenko V, Lysenko G, Miranda P, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72(10):1605–12.
219. Park W, Hrycaj P, Kovalenko V, Miranda P, Gutierrez-Ureña S, Lee Y, et al. A randomized, double-blind, phase 1 study demonstrates equivalence in pharmacokinetics, safety, and efficacy of CT-P13 and infliximab in patients with ankylosing spondylitis. Ann Rheum Dis. 2012;71:111.
220. Park W, Miranda P, Brzosko M, Wiland P, Gutierrez-Urena S, Mikazane H, et al. Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with ankylosing spondylitis: comparison between continuing with CT-P13 and switching from infliximab to CT-P13. Arthritis Rheum. 2013;65:3326.
221. Park W, Yoo DH, Szántό S, Berghea F, Brzosko M, Wiland P, et al. Clinical response of disease activity, disability and mobility indices in relation to anti-drug antibody in the PLANETAS. Ann Rheum Dis. 2014;73:121. doi:10.1136/annrheumdis-2014-eular.3804.
222. Pierri CL, Cetrone M, Punzi G, Tricarico D. Therapeutic anti-TNF alpha antibodies: structure-activity investigations. FASEB J. 2015;29(1 Suppl):941.9.
223. Yoo DH. Disease activity assessment using the DAS28, CDAI and SDAI and effect of anti-drug antibody on clinical response in a randomised, double-blind, comparative trial of CT-P13 and the innovator infliximab: PLANETRA study. Ann Rheum Dis. 2014;72.
224. Yoo D, Miranda P, Piotrowski M, Ramiterre E, Kovalenko V, Prodanovic N, et al. A randomized, double-blind, Phase 3 study demonstrates clinical equivalence of CT-P13 to infliximab when co-administered with methotrexate in patients with active rheumatoid arthritis. Ann Rheum Dis. 2012;71:359.
225. Yoo D, Park W, Miranda P, Piotrowski M, Ramiterre E, Shevchuk S, et al. Inhibition of radiographic progression and its association with clinical parameters in RA patients treated with CT-P13 and innovator infliximab in PLANETRA study. Ann Rheum Dis. 2014;73:234–5.
226. Yoo DH, Prodanovic N, Jaworski J, Miranda P, Ramiterre EB, Lanzon A. Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with rheumatoid arthritis: comparison between continued CT-P13 and switching from infliximab to CT-P13. American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting 25–30 October 2013; San Diego, CA: 26–9.
227. Yoo DH, Racewicz A, Brzezicki J, Yatsyshyn R, Arteaga ET, Baranauskaite A, et al. A Phase 3 randomised controlled trial to compare CT-P13 with infliximab in patients with active rheumatoid arthritis: 54 week results from the PLANETRA study. Ann Rheum Dis. 2013;72:A73.
228. Yoo DH, Shevchuk S, Ramiterre E, Kovalenko V, Tee M, Tobias Arteaga E, et al. Local tuberculosis incidence affects the rate of positive conversion in the quantiferon (R)-tb gold test among patients receiving infliximab or CT-P13 therapy. Ann Rheum Dis. 2013;72:426–7.
229. Yoo DH, Yagensky A, Toncheva A, Ruiz Santacruz O, Cons Molina F, Bae Y, et al. Impact of CT-P13 and originator infliximab treatment on quality of life derived from the health assessment questionnaire (HAQ) and short-form 36 (SF-36) from a randomized, double-blind trial in patients with active RA. Arthritis Rheum. 2013;65(Suppl 10):2392.
230. Yoon Suk J, Park DI, Kim YH, Seo PJ, Kim JW, et al. Efficacy and safety of infliximab’s biosimilar (REMSIMA) for IBD. J Crohns Colitis. 18-21 February 2015;9 Suppl 1:S340–S50.
231. ClinicalTrials.gov. Demonstrate noninferiority in efficacy and to assess safety of CT-P13 in patients with active Crohn’s Disease. 11 Feb 2016. Available from: https://clinicaltrials.gov/show/NCT02096861. Accessed 2016 Jun 21.
232. ClinicalTrials.gov. Efficacy and safety of infliximab-biosimilar (Inflectra) compared to infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission: the SIMILAR trial (SIMILAR). 21 May 2015. Available from: https://clinicaltrials.gov/show/NCT02452151. Accessed 2016 Jun 21.
233. ClinicalTrials.gov. The NOR-SWITCH study (NOR-SWITCH). 17 June 2016. Available from: https://clinicaltrials.gov/show/NCT02148640. Accessed 2016 Jun 21.
234. Johnson T, Derzi M, Bolt M, Conlon H, Kirchhoff C, Lorello L, et al. Comparative nonclinical assessments of marketed infliximab presentations (Remicade) and the potential biosimilar PF-06438179. American Association of Pharmaceutical Scientists (AAPS) National Biotechnology Conference; 2-4 November 2014; San Diego, CA: W3065.
235. McClellan JE, Udata C, Yin D, Salts S, Johnson TR, Derzi M, et al. Comparative structural, functional, nonclinical, and phase 1 similarity assessments of PF-06438179, a potential biosimilar to infliximab, and marketed reference products. J Crohns Colitis. 2015;2015(9 Suppl 1):S94–5.
236. Sharpe P, Saati A, Koob S, Gu L, Aggarwal P, Porter T, et al. Characterization and similarity assessment of infliximab and PF-06438179: A proposed biosimilar. American Association of Pharmaceutical Scientists (AAPS) National Biotechnology Conference; 2-4 November 2014; San Diego, CA: Abstract no. T2022.
237. Udata C, Yin D, Cai C-H, Salts S, Hua SY, Rehman MI, et al. Immunogenicity assessment of PF-06438179, a potential biosimilar to infliximab, in healthy volunteers. Arthritis Rheum. 2014;66:S660.
238. Udata C, Yin DHCC, Hua SY, Salts S, Rehman ML, Meng X. Immunogenicity assessment of PF-06438179, a potential biosimilar to infliximab, in healthy volunteers. Ann Rheum Dis. 2015;74:702. http://acrabstracts.org/abstract/immunogenicity-assessment-of-pf-06438179-a-potential-biosimilar-to-infliximab-in-healthy-volunteers/.
239. Yin D, Udata C, Hua S, Salts S, Meng X, Johnson TR, et al. Comparative assessments of PF-06438179, a potential biosimilar, and infliximab in a Phase 1 pharmacokinetic study. Gastroenterology. 2015;148(4):S-642.
240. ClinicalTrials.gov. A Study of PF-06438179 (infliximab-Pfizer) and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis (REFLECTIONS B537-02). 25 March 2016. Available from: https://clinicaltrials.gov/show/NCT02222493. Accessed 2016 Jun 21.
241. ®) in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rhuem Dis. 2015;74:706–7.
242. ClinicalTrials.gov. Comparison of CHS-0214 to Enbrel (etanercept) in patients with rheumatoid arthritis (RA) (CHS-0214-02). 5 Jan 2016. Available from: https://clinicaltrials.gov/show/NCT02115750. Accessed 2016 Jun 21.
243. ClinicalTrials.gov. A long term safety extension study (CHS-0214-05). 17 May 2016. Available from: https://clinicaltrials.gov/show/NCT02486939. Accessed 2016 Jun 21.
244. ClinicalTrials.gov. Comparison of CHS-0214 to Enbrel (etanercept) in patients with chronic plaque psoriasis (PsO). 10 Aug 2015. Available from: https://clinicaltrials.gov/show/NCT02134210. Accessed 2016 Jun 21.
245. Gu NY, Kim BR, Kim BH, Kim JW, Song DH, Shin SG, et al. Comparative pharmacokinetics/tolerability of TUNEX and ENBREL in healthy Korean volunteers. Clin Pharmacol Ther. 2010;87:S93-S.
246. ClinicalTrials.gov. A prospective, randomized, double-blind, placebo-controlled, parallel-group, multicentre, phase III study to evaluate the efficacy and safety of ENIA11 in combination with DMARDs versus DMARDs alone in patients with rheumatoid arthritis. 12 April 2016. Available from: https://clinicaltrials.gov/show/NCT01787149. Accessed 2016 Jun 21.
247. da Silva A, Kronthaler U, Fritsch C, Poetzl J, Rohde A, Papandrikopoulou A, et al. Target-directed development of a proposed etanercept biosimilar, GP2015: comparability of in vitro target binding and neutralization, and in vivo efficacy and pharmacokinetics with the reference product etanercept at the pre-clinical level. Congress of the European Academy of Dermatology and Venereology (EADV); 2-6 October 2013; Istanbul, Turkey: P304.
248. da Silva A, Kronthaler U, Fritsch C, Poetzl J, Rohde A, Papandrikopoulou A, et al. Target-directed development of a proposed biosimilar etanercept, GP2015: Comparability of in vitro target binding and pre-clinical efficacy and pharmacokinetics. Arthritis Rheum. 2013;65(S10):S794.
249. ClinicalTrials.gov. Study to demonstrate equivalent efficacy and to compare safety of biosimilar etanercept (GP2015) and Enbrel (EGALITY). 26 Oct 2015. Available from: https://clinicaltrials.gov/show/NCT01891864. Accessed 2016 Jun 21]
250. ® in combination with methotrexate (MTX) in patients with RA; The HERA study. Value Health. 2014;7(17):A374.
251. ClinicalTrials.gov. Safety and pharmacokinetic characteristics of HD203 liq. in healthy subjects. 3 July 2013. Available from: https://clinicaltrials.gov/show/NCT01431404. Accessed 2016 Jun 21.
252. ClinicalTrials.gov. Safety and pharmacokinetic characteristics of HD203 liquid in healthy male volunteers. 13 July 2014. Available from: https://clinicaltrials.gov/show/NCT01894412. Accessed 2016 Jun 21.
253. ®. 17 Feb 2011. Available from: https://clinicaltrials.gov/show/NCT01145950. Accessed 2016 Jun 21.
254. ® in subjects with active rheumatoid arthritis despite methotrexate therapy. 5 Jan 2016. Available from: https://clinicaltrials.gov/show/NCT02357069. Accessed 2016 Jun 21.
255. Ebbers HC, van Meer PJ, Moors EH, Mantel-Teeuwisse AK, Leufkens HG, Schellekens H. Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumab. Drug Discov Today. 2013;18(17–18):872–9.
256. Li E, Subramanian J, Anderson S, Thomas D, McKinley J, Jacobs IA. Development of biosimilars in an era of oncologic drug shortages. Drug Des Devel Ther. 2015;9:3247–55.
257. Biosimilars Dhingra K. The industry perspective. J Crohns Colitis. 2009;3(Suppl 1):78.
258. Beck A, Sanglier-Cianferani S, Van Dorsselaer A. Biosimilar, biobetter, and next generation antibody characterization by mass spectrometry. Anal Chem. 2012;84(11):4637–46.
259. Kurbanova EK, Chulkova TY, Byrikhina DV, Dano AO, Nikolaeva VA, Gusarov DA. PHARMA-2020: technological aspects of production of some strategical biopharmaceuticals. J Biopharm. 2012;4:21–45.
260. Guo W, Chen Y. J W. Considerations for biosimilar monoclonal antibody development: Lessons learned from clinical trials of trastuzumab. Chinese. J Cancer Biotherapy. 2014;4:359–65.
261. Nelson KM, Gallagher PC. Biosimilars lining up to compete with Herceptin–opportunity knocks. Expert Opin Ther Pat. 2014;24(11):1149–53.
262. No authors listed. What are biosimilars and are they important? Drug Ther Bull. 2013;51(5):57–60.
263. Thill M. New frontiers in oncology: biosimilar monoclonal antibodies for the treatment of breast cancer. Expert Rev Anticancer Ther. 2015;15(3):331–8.
264. Araujo F, Cordeiro I, Teixeira F, Goncalves J, Fonseca JE. Pharmacology of biosimilar candidate drugs in rheumatology: a literature review. Acta Reumatol Port. 2014;39(1):19–26.
265. da Silva A, Grau R, Stangler T, et al. Comprehensive target-directed approach for the development of a highly-comparable rituximab biosimilar. Ann Rheum Dis. 2012;71:718.
266. Smolen J, Landewe R, Breedveld FC, Buch M, Burmester G, Dougados M. EULAR recommendations for the managements of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 Update. Rheumatologia. 2014;28:1–25.
267. Smolen JS, Landewe R, Breedveld FC, Buch M, Burmester G, Dougados M, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014;73(3):492–509.
268. Smolen JS, van der Heijde D, Machold KP, Aletaha D, Landewe R. Proposal for a new nomenclature of disease-modifying antirheumatic drugs. Ann Rheum Dis. 2014;73(1):3–5.
269. Brown PM, Isaacs JD. Rheumatoid arthritis: an evolutionary force in biologics. Curr Pharm Des. 2015;21(17):2170–8.
270. Cragg MS. CD20 antibodies: doing the time warp. Blood. 2011;118(2):219–20.
271. Goel N, Chance K. The biosimilar landscape: a systematic review of its current status. Arthritis Rheum. 2014;74:S662.
272. Nam JL, Ramiro S, Gaujoux-Viala C, Takase K, Leon-Garcia M, Emery P, et al. Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2013 update of the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis. 2014;73(3):516–28.
273. Rioufol C, Salles G. Biosimilar monoclonal antibodies in lymphoma: a critical appraisal. Expert Rev Anticancer Ther. 2015;15(5):569–78.
274. Vital EM, Kay J, Emery P. Rituximab biosimilars. Expert Opin Biol Ther. 2013;13(7):1049–62.
275. Kay J. Biosimilars: a regulatory perspective from America. Arthritis Res Ther. 2011;13(3):112.
276. Kudrin A, Knezevic I, Joung J, Kang HN. Case studies on clinical evaluation of biosimilar monoclonal antibody: Scientific considerations for regulatory approval. Biologicals. 2015;43(1):1–10.
277. Chamberlain P. Assessing immunogenicity of biosimilar therapeutic monoclonal antibodies: regulatory and bioanalytical considerations. Bioanalysis. 2013;5(5):561–74.
278. Urbano PC, Soccol VT, Azevedo VF. Apoptosis and the FLIP and NF-kappa B proteins as pharmacodynamic criteria for biosimilar TNF-alpha antagonists. Biologics. 2014;8:211–20.
279. Thivolet M, Remuzat C, Kornfeld A, Toumi M. Dispensation channels of anti-TNFs in inflammatory bowel disease. Value Health. 2013;16:A501.
280. Arguelles-Arias F, Barreiro-de-Acosta M, Carballo F, Hinojosa J, Tejerina T. Joint position statement by “Sociedad Espanola de Patologia Digestiva” (Spanish Society of Gastroenterology) and “Sociedad Espanola de Farmacologia” (Spanish Society of Pharmacology) on biosimilar therapy for inflammatory bowel disease. Rev Esp Enferm Dig. 2013;105(1):37–43.
281. Nast A, Rosumeck S, Seidenschnur K. Biosimilars: a systematic review of published and ongoing clinical trials of antipsoriatics in chronic inflammatory diseases. J Dtsch Dermatol Ges. 2015 Ar;13(4):294–300.
282. Lawrance IC. Early investigational TNF receptor antagonists for the treatment of ulcerative colitis. Expert Opin Investig Drugs. 2015;24(6):761–8.
283. Willrich MA, Murray DL, Snyder MR. Tumor necrosis factor inhibitors: clinical utility in autoimmune diseases. Transl Res. 2015;165(2):270–82.
284. Radtke MA, Augustin M. Biosimilars in psoriasis: what can we expect? J Dtsch Dermatol Ges. 2014;12(4):306–12.
285. Kasap Y, Aydinkarahaliloglu DN, Aykac E, et al. The drugs monitored by TUFAM with Risk Management Plan (RMP). Drug Saf. 2011;34:906–7.
286. Braun J, Kudrin A. Progress in biosimilar monoclonal antibody development: the infliximab biosimilar CT-P13 in the treatment of rheumatic diseases. Immunotherapy. 2015;7(2):73–87.
287. McKeage K. A review of CT-P13: an infliximab biosimilar. BioDrugs. 2014;28(3):313–21.
288. Feagan BG, Choquette D, Ghosh S, Gladman DD, Ho V, Meibohm B, et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals. 2014;42(4):177–83.
289. Annese V, Vecchi M. Use of biosimilars in inflammatory bowel disease: Statements of the Italian Group for Inflammatory Bowel Disease. Dig Liver Dis. 2014;46(11):963–8.
290. New treatment option for chronic inflammatory diseases: Remsima-the first biosimilar infliximab. Verdauungskrankheiten. 2015;33(2):108–9.
291. Ainsworth M. Is extrapolation of safety and efficacy data possible? Karger. 2015;34:107–12.
292. Castaneda-Hernandez G, Szekanecz Z, Mysler E, Azevedo VF, Guzman R, Gutierrez M, et al. Biopharmaceuticals for rheumatic diseases in Latin America, Europe, Russia, and India: innovators, biosimilars, and intended copies. Joint Bone Spine. 2014;81(6):471–7.
293. Dorner T, Kay J. Biosimilars in rheumatology: current perspectives and lessons learnt. Nat Rev Rheumatol. 2015;11(12):713–24.
294. Dreesen E, Gils A. Neutralisation of soluble tumor necrosis factor. Front Gastrointest Res. 2015;34:83–9.
295. Gomollon F. Biosimilars: are they bioequivalent? Dig Dis. 2014;32(Suppl 1):82–7.
296. Gomollon F. Biosimilars in inflammatory bowel disease: ready for prime time? Curr Opin Gastroenterol. 2015;31(4):290–5.
297. Hlavaty T, Letkovsky J. Biosimilars in the therapy of inflammatory bowel diseases. Eur J Gastroenterol Hepatol. 2014;26(6):581–7.
298. Lukas M. Remsima™: the first biosimilar infliximab. Gastroent Hepatol. 2014;68:178–9.
299. Papamichael K, Van Stappen T, Jairath V, Gecse K, Khanna R, D’Haens G, et al. Review article: pharmacological aspects of anti-TNF biosimilars in inflammatory bowel diseases. Aliment Pharmacol Ther. 2015;42(10):1158–69.
300. Richardson B. Biosimilars in perspective: regulation. Rheumatol. 2014;53:i5–6.
301. Rinaudo-Gaujous M, Paul S, Tedesco ED, Genin C, Roblin X, Peyrin-Biroulet L. Review article: biosimilars are the next generation of drugs for liver and gastrointestinal diseases. Aliment Pharmacol Ther. 2013;38(8):914–24.
302. Schreiber S, Luger T, Mittendorf T, Mrowietz U, Muller-Ladner U, Schroder J, et al. Evolution of biologicals in inflammation medicine–biosimilars in gastroenterology, rheumatology and dermatology. Dtsch Med Wochenschr. 2014;139(47):2399–404.
303. Teixeira FV, Kotze PG, Damiao AO, Miszputen SJ. Biosimilars in inflammatory bowel diseases: an important moment for Brazilian gastroenterologists. Arq Gastroenterol. 2015;52(1):76–80.
304. Urbánek K. First biosimilar monoclonal antibody introduced to clinical praxis: Infliximab. Klin Farmakol Farm. 2014;28:19–22.
305. Wiland P. Biosymilars in the treatment of rheumatic diseases. Reumatologia. 2013;51:399–408.
306. Yoo DH. The rise of biosimilars: potential benefits and drawbacks in rheumatoid arthritis. Expert Rev Clin Immunol. 2014;10(8):981–3.
307. Declerck PJ. Biologicals and biosimilars: is similar the same? J Crohns Colitis. 2014;8(Suppl 1):S427.
308. Yamaguchi T. Current situations and the future prospect of monoclonal antibody products. Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 2014;132:36–46.
309. Genazzani A, Altomare G, Balato N, Cusano F, De Pita O, Loconsole F, et al. Biosimilar infliximab: an expert view. G Ital Dermatol Venereol. 2015;150(4):449–59.
310. Baek K. Regulatory framework on biosimilar in Korea [abstract]. 10th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry (Mass Spec 2013); 23–26 2013; Boston, MA: 34.
311. Esplugues Mota JV. Biosimilars: Potential clinical differences and European regulatory aspects. Ann Rheum Dis. 2014;73:7–8.
312. Kim YS, Choi BW, Yang SW, Shin SM, Nam SW, Roh YS, et al. Biosimilars: challenges and path forward. Biotechnol Bioprocess Eng. 2014;19(5):755–65.
313. Lee H. Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars? AAPS J. 2014;16(1):22–6.
314. Puig L, Carretero G, Dauden E, Ferrandiz C, Marron SE, Martorell A, et al. Biosimilars in dermatology: current situation (Part I). Actas Dermosifiliogr. 2015;106(7):545–9.
315. Puig L, Carretero G, Dauden E, Ferrandiz C, Marron SE, Martorell A, et al. Biosimilars in dermatology: current situation (Part II). Actas Dermosifiliogr. 2015;106(7):550–4.
316. Richardson P. EU regulatory update [abstract]. 9 December 2013. Available from: https://c.ymcdn.com/sites/www.casss.org/resource/resmgr/imported/CMCJapan2013_FINALProgram_forWebsite.pdf. Accessed 2016 Jun 24.
317. Schellekens H, Lietzan E, Faccin F, Venema J. Biosimilar monoclonal antibodies: the scientific basis for extrapolation. Expert Opin Biol Ther. 2015;15(11):1633–46.
318. Scott BJ, Klein AV, Wang J. Biosimilar monoclonal antibodies: A Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation. J Clin Pharmacol. 2015;55(Suppl 3):S123–32.
319. Siu EC, Wyatt G. Canadian public reimbursement of subsequent entry biologics (SEBS)/biosimilars. Value Health. 2015;18(3):A168–9.
320. Young KE, Rémuzat C, Urbinati D, Toumi M. Boosting biosimilars uptake in European countries. Value Health. 2014;17:A408–9.
321. Reinisch W, Smolen J. Biosimilar safety factors in clinical practice. Semin Arthritis Rheum. 2015;44(6 Suppl):S9–15.
322. Zrubka Z, Vezer B, Sebeszta M. Authorised manufacturing changes of therapeutic monoclonal antibodies in EPAR documents. Ann Rheum Dis. 2015;74:A94.
323. Fonseca JE, Goncalves J, Araujo F, Cordeiro I, Teixeira F, Canhao H, et al. The Portuguese Society of Rheumatology position paper on the use of biosimilars. Acta Reumatol Port. 2014;39(1):60–71.
324. Pavelka K. EULAR recommendations for the management of rheumatoid arthritis - differences between versions from 2013 and 2010. Čes Revmatol. 2014;22:70–80.
325. Amiot A, Peyrin-Biroulet L. Current, new and future biological agents on the horizon for the treatment of inflammatory bowel diseases. Therap Adv Gastroenterol. 2015;8(2):66–82.
326. Feldman SR. Inflammatory diseases: Integrating biosimilars into clinical practice. Semin Arthritis Rheum. 2015;44(6 Suppl):S16–21.
327. Fonseca JE. The therapeutic landscape in RA—BDMARDS biosimilars and beyond. Ann Rheum Dis. 2015;74:2.
328. Puig L. Biosimilars in dermatology: starting with infliximab. Actas Dermosifiliogr. 2013;104(3):175–80.
329. Braun J. Latest update on biosimilars-chances and risks. Ann Rheum Dis. 2014;73:32.
330. Woron J, Kocic I. The story of biosimilars–chance or threat?. Pol Merkur Lekarski. 2014;37(221):311–5.
331. Strojil J. Biosimilars—specific features of the approval process in the European Union. Klin Farmakol Farm. 2014;28:14–8.
332. Choy E, Jacobs IA. Biosimilar safety considerations in clinical practice. Semin Oncol. 2014;41(Suppl 1):S3–14.
333. Geiler J, Buch M, McDermott MF. Anti-TNF treatment in rheumatoid arthritis. Curr Pharm Des. 2011;17(29):3141–54.
334. Ma Y, Wang T, Ma Y, Lin B. Research progress of the clinical pharmacokinetics of etanercept and its biosimilars. Chinese J New Drugs. 2013;24:2896–902.
335. Pecen PE, Kaiser PK. Current phase 1/2 research for neovascular age-related macular degeneration. Curr Opin Ophthalmol. 2015;26(3):188–93.