Clinical considerations for the development of biosimilars in oncology

mAbs

Volumn 7, Issue 2, 2015, Pages 286-293

  Socinski, Mark A ^a   Curigliano, Giuseppe ^b   Jacobs, Ira ^c   Gumbiner, Barry ^c   MacDonald, Judith ^d   Thomas, Dolca ^c  

^a UNIVERSITY OF PITTSBURGH   (United States)

^b EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

^c PFIZER INC   (United States)

^d PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

Author keywords

Biologic therapy; Biosimilar; Clinical; Monoclonal antibody; Regulatory

Indexed keywords

BIOSIMILAR AGENT;

CANCER THERAPY; DRUG APPROVAL; DRUG INFORMATION; DRUG LABELING; DRUG UPTAKE; HUMAN; ONCOLOGY; REVIEW; ANIMAL; FOOD AND DRUG ADMINISTRATION; NEOPLASMS; PRACTICE GUIDELINE; UNITED STATES;

ANIMALS; BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; GUIDELINES AS TOPIC; HUMANS; NEOPLASMS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84924733846     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.1080/19420862.2015.1008346     Document Type: Review

References (54)

1. American Cancer Society, LIVESTRONG. The Global Economic Cost of Cancer. Atlanta, GA: American Cancer Society; 2010. http://www.cancer.org/acs/ groups/content/@internationalaffairs/documents/docu ment/acspc-026203.pdf
2. Knaul F, Arreola-Ornelas H, Méndez O, Alsan M, Seinfeld J, Marx A, Atun R. The global economic burden of cancer. In: Stewart B, Wild C, eds. World Cancer Report 2014. Lyon, France: International Agency for Research on Cancer (IARC)/World Health Organization (WHO) Press; 2014.
3. Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, Brown ML. Projections of the cost of cancer care in the United States: 2010-2020. J Natl Cancer Inst 2011; 103 (2):117-28; PMID:21228314; http://dx.doi.org/ 10.1093/jnci/djq495
4. McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther 2012; 91(3):405-17; PMID:22318617; http://dx.doi. org/10.1038/clpt.2011.343
5. Pallis A, Tsiantou V, Simou E, Maniadakis N. Pharmacoeconomic considerations in the treatment of breast cancer. Clinicoecon Outcomes Res 2010; 2:47-61; PMID:21935314
6. Cornes P. The economic pressures for biosimilar drug use in cancer medicine. Target Oncol 2012; 7 (Suppl 1):S57-67; PMID:22249658; http://dx.doi.org/ 10.1007/s11523-011-0196-3
7. European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Guideline on Similar Biological Medicinal Products Containing Biotechnol-ogy-derived Proteins as Active Substance: Non-clinical and Clinical Issues. Draft. London: European Medicines Agency; 2013. http://www.ema.europa.eu/docs/en-GB/ document-library/Scientific-guideline/2013/06/WC500144124.pdf
8. Health Canada, Health Products and Food Branch. Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs) [Internet]. Ottawa Ontario: Health Canada; 2005.http://www.hc-sc.gc.ca/dhp-mps/alt-formats/pdf/ brgtherap/applic-demande/guides/seb-pbu/seb-pbu-2010-eng.pdf
9. US Food and Drug Administration. Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Draft Guidelines [Internet]. Washington, DC: US Department of Health and Human Services, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER); 2012. A http://www.fda. gov/downloads/Drugs/GuidanceComplianceRegulator yInformation/Guidances/UCM291128.pdf
10. World Health Organization Expert Committe on Biological Standardization. Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs) [Internet]. Geneva, Switzerland: World Health Organization; 2009 [updated WHO Techincal Report Series no. 977-2013 Annex 2]. http://www.who.int/biologicals/ areas/biological-therapeutics/BIOTHERAPEUTICS- FOR-WEB-22APRIL2010.pdf
11. Schneider CK. Towards biosimilar monoclonal antibodies pros and cons. EMEA Workshop on Biosimilar Monoclonal Antibodies. Proceedings of the EMEA Workshop on Biosimilar Monoclonoal Antibodies; July 2, 2009; London.
12. European Medicines Agency, Committee for Medicinal Products forHuman Use (CHMP). Guideline on Similar Biological Medicinal Products Containing Biotechnol-ogy-derived Proteins as Active Substance: Quality Issues (Revision 1) [Internet]. London: European Medicines Agency; 2012. http://www.ema.europa.eu/docs/en-GB/ document-library/Scientific-guideline/2012/05/WC500127960.pdf
13. Chow SC, Liu JP. Statistical assessment of biosimilar products. J Biopharm Stat 2010; 20(1):10-30; PMID:20077246; http://dx.doi.org/10.1080/ 10543400903280266
14. Yin D, Barker KB, Li R, Meng X, Reich SD, Ricart AD, Rudin D, Taylor CT, Zacharchuk CM, Hansson AG. A randomised phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS B327-01). Br J Clin Pharmacol 2014; 78: 1281-90. PMID: 25041377; http://dx.doi.org/10.1111/bcp.12464
15. European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies - Non-clinical and Clinical Issues [Internet]. London: European Medicines Agency;2012. http://www.ema.europa.eu/docs/en-GB/docu ment-library/Scientific-guideline/2012/06/WC500128686.pdf
16. European Medicines Agency, Oncology Working Party. Guideline on the Evaluation of Anticancer Medicinal Products in Man. Draft. London: European Medicines Agency; 2012. http://www.ema.europa.eu/docs/en-GB/ document-library/Scientific-guideline/2013/01/WC500137128.pdf
17. US Food and Drug Administration. Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. Available at: (accessed July 28, 2014). Washington DC: US Department of Health and Human Services, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER); 2007. http://www.fda. gov/downloads/drugs/guidancecomplianceregulatoryin formation/guidances/ucm071590.pdf
18. Hotta K, Kiura K, Fujiwara Y, Takigawa N, Oze I, Ochi N, Tabata M, Tanimoto M. Association between incremental gains in the objective response rate and survival improvement in phase III trials of first-line chemotherapy for extensive disease small-cell lung cancer. Ann Oncol 2009; 20(5):829-34; PMID:19221150; http://dx.doi.org/10.1093/annonc/mdp020
19. Lee L, Wang L, Crump M. Identification of potential surrogate end points in randomized clinical trials of aggressive and indolent non-Hodgkin's lymphoma: correlation of complete response, time-to-event and overall survival end points. Ann Oncol 2011; 22 (6):1392-403; PMID:21266519; http://dx.doi.org/ 10.1093/annonc/mdq615
20. Scappaticci F, Burger H, Bisordi F, Ruiz de Erenchun F, Schreitmueller T. Neoadjuvant-adjuvant treatment of breast cancer: a model for extrapolation of clinical data for trastuzumab biosimilar candidates. Proceedings of the 2013 Annual Meeting of the European Cancer Congress; September 27-October 1, 2013; Amsterdam, The Netherlands.
21. Aradi I. European Generic Medicines Association (EGA). Biosimilar Industry Perspective on Clinical Issues - Equivalence versus Non-inferiority 2.2 [Internet]. London: EGA; 2011. http://www.ema.europa.eu/ docs/en-GB/document-library/Presentation/2012/06/ WC500128718.pdf
22. Dasgupta A, Lawson KA, Wilson JP. Evaluating equivalence and noninferiority trials. Am J Health Syst Pharm 2010; 67(16):1337-43; PMID:20689122; http://dx.doi.org/10.2146/ajhp090507
23. European Medicines Agency, Patient Health Protection. QRD General Principles Regarding the SmPC Information for a Generic/Hybrid/Biosimilar Product. EMA/627621/2011; Patient Health Protection [Internet]. London: European Medicines Agency; 2012.http://www.ema.europa.eu/docs/en-GB/document-li brary/Regulatory-and-procedural-guideline/2012/05/ WC500127589.pdf
24. Celltrion Healthcare Hungary Kft. Summary of Product Characteristics: Remsima (infliximab) European Public Assessment Report [Internet]. Budapest, Hungary:2014. http://www.ema.europa.eu/docs/en-GB/ document-library/EPAR-Product-Information/hu man/002576/WC500150871.pdf
25. Hospira UK LImited. Summary of Product Characteristics: Inflectra (infliximab) European Public Assessment Report [Internet]. Warwickshire, UK: Hospira UK Limited; 2014. http://www.ema.europa.eu/docs/ en-GB/document-library/EPAR-Product-Informa tion/human/002778/WC500151489.pdf
26. European Biopharmaceutical Enterprises (EBE). Position Paper on Labelling of Biosimilars -Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) - Draft April 2013 (FINAL EBE 21August 2013) [Internet]. Brussels: European Biopharamceutical Enterprises; 2013. http://www.ebe-bio pharma.eu/uploads/Modules/Documents/ebe-position-paper-labelling-3-07-2013.pdf
27. European Medicines Agency. European Public Assessment Reports (EPAR). London: European Medicines Agency; 2014. http://www.ema.europa.eu/ema/index. jsp?curl Dpages/ medicines/landing/epar-search.jsp&m id=WC0b01ac058001d125
28. EuropaBio. EuropaBio Statement on Labelling of Biosimilars. Brussels, Belgium: EuropaBio; 2014. http:// www.europabio.org/positions/europabio-statement-lab elling-biosimilars
29. Casadevall N, Edwards IR, Felix T, Graze PR, Litten JB, Strober BE, Warnock DG. Pharmacovigilance and biosimilars: considerations, needs and challenges. Expert Opin Biol Ther 2013; 13(7):1039-47; PMID:23527621; http://dx.doi.org/10.1517/ 14712598.2013.783560
30. US Food and Drug Administration. Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment [Internet]. Washington, DC: U.S. Department of Health and Human Services, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER); 2005. http://www.fda.gov/downloads/regula toryinformation/guidances/ucm126834.pdf
31. Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood 2014; PMID:25298038
32. Health Canada. Summary Basis of Decision (SBD) for Remsima. Ottawa, Ontario: Health Canada Office of Regulatory Affairs, Biologics and Genetic Therapies Directorate; 2014. http://www.hc-sc.gc.ca/dhp-mps/ prodpharma/sbd-smd/drug-med/sbd-smd-2014-rem sima-160195-eng.php#sbd
33. Health Canada. Summary Basis of Decision (SBD) for Inflectra [Internet]. Ottawa, Ontario: Health Canada;2014. http://www.hc-sc.gc.ca/dhp-mps/prodpharma/ sbd-smd/drug-med/sbd-smd-2014-inflectra-159493-eng.php
34. Schneider CK, Vleminckx C, Gravanis I, Ehmann F, Trouvin JH, Weise M, Thirstrup S. Setting the stage for biosimilar monoclonal antibodies. Nat Biotechnol 2012; 30(12):1179-85; PMID:23222783; http://dx. doi.org/10.1038/nbt.2447
35. Gascon P, Tesch H, Verpoort K, Rosati MS, Salesi N, Agrawal S, Wilking N, Barker H, Muenzberg M, Turner M. Clinical experience with Zarzio(R) in Europe: what have we learned? Support Care Cancer 2013; 21(10):2925-32; PMID:23903799; http://dx. doi.org/10.1007/s00520-013-1911-7
36. Henry D, Taylor C. Pharmacoeconomics of cancer therapies: considerations with the introduction of biosimilars. Semin Oncol 2014; 41 Suppl 3:S13-20; PMID:24767632; http://dx.doi.org/10.1053/j. seminoncol.2014.03.009
37. US Congressional Budget Office. Cost estimate: S.1695 Biologics Price Competition and Innovation Act of 2007 [Internet]. Washington, DC: United States Federal Government; 2007. http://www.cbo.gov/sites/ default/files/cbofiles/ftpdocs/94xx/doc9496/s1695.pdf
38. Orlov S, Burdaeva O, Nechaeva M, Kopp M, Kotiv B, Sheveleva L, Gladkov O, Khorinko A, Prokopenko T, Shapovalova J, et al. Pharmacokinetics and safety of BCD-021, bevacizumab biosimilar candidate, compared to Avastin in patients. Abstract e13500. J Clin Oncol 2014; 32(Suppl).
39. Grunder B, Costigan L, Johnson K, Kneeland T, Cirelli D, Dufield R, Kitchen R, Porter T, Rouse J, K R. Characterization and similarity assessment of bevacizumab and a proposed biosimilar. 2014 Annual Meeting & Exposition of the American Association ofPharmaceutical Scientists (AAPS); November 2-6, 2014; San Diego, CA. 2014; AbstractW3549.
40. Peraza M. Nonclinical development of proposed biosimilars to monoclonal antibodies: trastuzumab and bevacizumab. Proceedings of the Applied Pharmaceutical Toxicology (APT); May 14-16, 2014; Gaithersburg, MD.
41. Poddubnaya I, Babicheva L, Kaplanov K, Zaritskey A, Volodicheva E, Alexeev S, Loginov A, Orlova R, Dvornichenko V, Gladkov O, et al. Comparison of pharmacokinetics and pharmacodynamics of BCD-020 with innovator rituximab in patients with indolent non-Hodgkin lymphoma. Abstract e19545. J Clin Oncol 2014; 32(Suppl).
42. Visser J, 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; PMID:23649935; http://dx.doi. org/10.1007/s40259-013-0036-3
43. da Silva A, Kronthaler U, Meyer I, Papandrikopoulou A, Stangler T, Visser J. 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. Arthritis Rheum 2012; 64(Suppl 10): Abstr 2153.
44. Yin D, Becker J-C, Melia L, Li R, Gumbiner B, Thomas D, Spencer-Green G, Meng X. A phase I pharmacokinetics trial comparing PF-05280586 (a potential biosimilar) and rituximab in subjects with active rheumatoid arthritis (REFLECTIONS B328-01). Annals of the Rheumatic Diseases 2014; 74 (Suppl 2): 497.http://dx.doi.org/10.1136/annrheumdis-2014-eular.5444
45. Becker J, Yin D, Melia L, Li R, Gumbiner B, Thomas D, Spencer-Green G, Meng X. A phase I trial comparing PF-05280586 (a potential biosimilar) and rituximab in subjects with active rheumatoid arthritis. Arthritis Rheumatol 2014; 66(Suppl).
46. Yoo D, Park W, Jeka S, Cons Molina F, Hrycaj P, Wiland P, Spieler W, Brzezicki J, Lee E, Medina-Rodriguez F, 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 [Abstr #1736]. Arthritis Rheumatol 2013; 65(Suppl): S736.
47. Yoo D, Park W, Jeka S, Cons Molina F, Hrycaj P, Wiland P, Spieler W, Lee E, Medina-Rodriguez F, Shesternya 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 Rheumatol 2014; 66(Suppl).
48. Yoo D, Park W, Jeka S, Cons Molina F, Hrycaj P, Wiland P, Spieler W, Brzezicki J, Lee E, Medina-Rodriguez F, 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 [Abstr #1736]. Arthritis Rheumatol 2013; 65(Suppl): S736.
49. Stenina M, Ignatova E, Frolova M, Burdaeva O, Nechaeva M, Kopp M, Udovitsa D, Kotiv B, Alekseev S, Stroyakovsky D, et al. Pharmacokinetics and safety of BCD-022, trastuzumab biosimilar candidate, compared to Herceptin in patients. Abstract e11576. J Clin Oncol 2014; 32(Suppl).
50. th St Gallen International Breast Cancer Conference Primary Therapy of Early Breast Cancer; March 13-16, 2013; Gallen, Switzerland.
51. Im Y-H, Odarchenko P, Grecea D, Komov D, Anatoliy C, Gupta S, Shparyk Y, Caguioa P, Makhson A, Krasnozhon D, 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. Abstract 629. J Clin Oncol 2013; 31(Suppl); PMID:23569309
52. th Annual Meeting of the San Antonio Breast Cancer Symposium; December 10-14, 2013; San Antonio, TX.
53. th Annual Meeting of the San Antonio Breast Cancer Symposium; December 9 -13, 2014; San Antonio, TX.
54. Hurst S, Ryan AM, Ng CK, McNally JM, Lorello LG, Finch GL, Leach MW, Ploch SA, Fohey JA, Smolarek TA. Comparative nonclinical assessments of the proposed biosimilar PF-05280014 and trastuzumab (Herceptin). BioDrugs 2014; 28(5):451-9; PMID:25001079; http://dx.doi.org/10.1007/s40259-014-0103-4