Position paper from the Spanish Society of Rheumatology on biosimilar drugs;Documento de posicionamiento de la Sociedad Española de Reumatología sobre fármacos biosimilares

Reumatologia Clinica

Volumn 11, Issue 5, 2015, Pages 269-278

  Hernández, Miguel Ángel Abad ^a   Andreu, José Luis ^b   Ruiz, Miguel Ángel Caracuel ^c   Serrano, Miguel Ángel Belmonte ^d   Díaz González, Federico ^e,f   Muelas, José Vicente Moreno ^g  

^a HOSPITAL VIRGEN DEL PUERTO   (Spain)

^b HOSPITAL UNIVERSITARIO PUERTA DE HIERRO   (Spain)

^c HOSPITAL UNIVERSITARIO REINA SOFÍA   (Spain)

^d HOSPITAL GENERAL DE CASTELLÓN   (Spain)

^e UNIVERSIDAD DE LA LAGUNA   (Spain)

^f HOSPITAL UNIVERSITARIO DE CANARIAS   (Spain)

^g HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

Author keywords

Biosimilars; Position paper; Review; Spanish Society of Rheumatology

Indexed keywords

BIOSIMILAR AGENT; ANTIRHEUMATIC AGENT;

ARTICLE; CONCEPTUAL FRAMEWORK; DRUG EFFICACY; EUROPEAN MEDICINES AGENCY; HEALTH CARE ACCESS; HEALTH CARE QUALITY; HEALTH CARE SYSTEM; HUMAN; MEDICAL SOCIETY; RHEUMATIC DISEASE; RHEUMATOLOGY; SPAIN; DRUG LEGISLATION; PRACTICE GUIDELINE; RHEUMATIC DISEASES;

ANTIRHEUMATIC AGENTS; BIOSIMILAR PHARMACEUTICALS; HUMANS; LEGISLATION, DRUG; RHEUMATIC DISEASES; RHEUMATOLOGY; SOCIETIES, MEDICAL; SPAIN;

EID: 84947021083     PISSN: 1699258X     EISSN: 18851398     Source Type: Journal    
DOI: 10.1016/j.reuma.2015.03.009     Document Type: Article

References (87)

1. Kelly C.J., Mir F.A. Economics of biological therapies. BMJ. 2009, 339:b3276.
2. Huggett B. Public biotech 2012-the numbers. Nat Biotechnol. 2013, 31:697-703.
3. Disponible en: [consultado 29 Ago 2014]. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002778/WC500151490.pdf.
4. Disponible en: [consultado 29 Ago 2014]. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf.
5. Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira (ADACCESS) [consultado 29 Ago 2014]. Disponible en: . https://clinicaltrials.gov/ct2/show/NCT02016105?term=biosimilar+adalimumab%26rank=1.
6. A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy [consultado 29 Ago 2014]. Disponible en: . https://clinicaltrials.gov/ct2/show/NCT02167139?term=biosimilar+adalimumab%26rank=2.
7. A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy [consultado 29 Ago 2014]. Disponible en: . https://clinicaltrials.gov/ct2/show/NCT01895309?term=etanercept+biosimilar%26rank=1.
8. Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel (EGALITY) [consultado 29 Ago 2014]. Disponible en: . https://clinicaltrials.gov/ct2/show/NCT01891864?term=etanercept+biosimilar%26rank=2.
9. Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA) (CHS-0214-02) [consultado 29 Ago 2014]. Disponible en: . https://clinicaltrials.gov/ct2/show/NCT02115750?term=etanercept+biosimilar%26rank=3.
10. Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis (Triad RA) [consultado 29 Ago 2014]. Disponible en: . https://clinicaltrials.gov/ct2/show/NCT01534884?term=biosimilar+rituximab+rheumatoid%26rank=1.
11. Study of Safety and Efficacy of BCD-020 Comparing to MabThera in Patients With Rheumatoid Arthritis [consultado 29 Ago 2014]. Disponible en: . https://clinicaltrials.gov/ct2/show/NCT01759030?term=biosimilar+rituximab+rheumatoid%26rank=2.
12. Disponible en: [consultado 29 Ago 2014]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500142978.pdf.
13. Disponible en: [consultado 29 Ago 2014]. http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedicines%2Flanding%2Fepar_search.jsp%26murl=menus%2Fmedicines%2Fmedicines.jsp%26mid=WC0b01ac058001d124%26searchTab=searchByAuthType%26alreadyLoaded=true%26isNewQuery=true%26status=Authorised%26status=Withdrawn%26status=Suspended%26status=Refused%26keyword=Enter+keywords%26searchType=name%26taxonomyPath=%26treeNumber=%26searchGenericType=biosimilars%26genericsKeywordSearch=Submit.
14. Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on products for human use. Official Journal of The European Communities L 159/46-94 [consultado 31 Ago 2014]. Disponible en: . http://ec.europa.eu/health/files/eudralex/vol-%201/dir_2003_63/dir_2003_63_en.pdf.
15. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC for medicinal products of Human use Official Journal of the European Community L 47:34-57 [consultado 31 Ago 2014]. Disponible en: . http://ec.europa.eu/health/files/eudralex/vol-1/dir_2004_27/dir_2004_27_en.pdf.
16. Disponible en: [consultado 11 Mar 2015]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf.
17. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues [consultado 31 Ago 2014]. Disponible en: . http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003953.pdf.
18. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues [consultado 31 Ago 2014]. Disponible en: . http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003953.pdf.
19. Disponible en: [consultado 31 Ago 2014]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/06/WC500167838.pdf.
20. Disponible en: [consultado 11 Mar 2015]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf.
21. Guideline on inmunogenicity assesment of biotechnology-derived medical products [consultado 31 Ago 2014]. Disponible en: . http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003946.pdf.
22. Disponible en: . [consultado 31 Ago 2014]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/03/WC500163623.
23. Guideline on similar biological medicinal products containing monoclonal antibodies -non- clinical and clinical issues [consultado 31 Ago 2014]. Disponible en: . http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf.
24. Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use [consultado 31 Ago 2014]. Disponible en: . http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128688.pdf.
25. Shaping the biosimilars opportunity. A global perspective on the evolving Biosimilar landscape [consultado 31 Ago 2014]. Disponible en: . http://www.imshealth.com/ims/Global/Content/Home%20Page%20Content/IMS%20News/Biosimilars_Whitepaper.pdf.
26. Mendes de Abreu M., Strand V., Levy R.A., Araujo D.V. Putting the value into biosimilar decision making: The judgment value criteria. Autoimmun Rev. 2014, 13:678-684.
27. Building a wall against biosimilars [editorial]. Nat Biotechnol. 2013, 31:264.
28. Kay J., Smolen J.S. Biosimilars to treat inflammatory arthritis: The challenge of proving identity. Ann Rheum Dis. 2013, 72:1589-1593.
29. Colbert R.A., Cronstein B.N. Biosimilars: The debate continues. Arthritis Rheum. 2011, 63:2848-2850.
30. McCamish M., Woollett G. The continuum of comparability extends to biosimilarity: How much is enough and what clinical data are necessary?. Clin Pharmacol Ther. 2013, 93:315-317.
31. Dörner T., Strand V., Castañeda-Hernández G., Ferraccioli G., Isaacs J.D., Kvien T.K., et al. The role of biosimilars in the treatment of rheumatic diseases. Ann Rheum Dis. 2013, 72:322-328.
32. Ruiz S., Calvo G. Similar biological medicinal products: Lessons learned and challenges ahead. Journal of Generic Medicines 2011, 8:4-13.
33. Weise M., Bielsky M.C., de Smet K., Ehmann F., Ekman N., Giezen T.J., et al. Biosimilars: What clinicians should know. Blood. 2012, 120:5111-5117.
34. Russell A.S., Ahluwalla V., Barnabe C., Jamal S., Offer R.C., Olszynski W.P., et al. Subsequent entry biologics/biosimilars: A viewpoint from Canada. Clin Rheumatol. 2012, 31:1289-1292.
35. Scheinberg M.A., Kay J. The advent of biosimilar therapies in rheumatology-'O brave new world'. Nat Rev Rheumatol. 2012, 8:430-436.
36. Schneider C.K., Kalinke U. Toward biosimilar monoclonal antibodies. Nat Biotecnology 2008, 26:950-985.
37. Fonseca J.E., Gonçalves J., Araújo F., Cordeiro I., Teixeira F., Canhão H., et al. The Portuguese Society of Rheumatology position paper on the use of biosimilars. Acta Reumatol Port. 2014, 39:60-71.
38. Espinosa Morales R., Díaz Borjón A., Barile Fabris L., Esquivel Valerio J.A., Medrano Ramírez G., Arce Salinas C.A., et al. Medicamentos biocomparables en México: la postura del Colegio Mexicano de Reumatología, 2012. Reumatol Clin. 2013, 9:113-116.
39. Fiorino G., Girolomoni G., Lapadula G., Orlando A., Danese S., Olivieri I., et al. The use of biosimilars in immune-mediated disease: A joint Italian Society of Rheumatology (SIR), Italian Society of Dermatology (SIDeMaST), and Italian Group of Inflammatory Bowel Disease (IG-IBD) position paper. Autoimmun Rev. 2014, 13:751.
40. ORA Subsequent Entry Biologic Position paper [consultado 1 Sep 2014]. Disponible en: . http://ontariorheum.ca/home/ora-subsequent-entry-biologic-position-paper.
41. ACR Posititon statement. Biosimilars [consultado 1 Sep 2014]. Disponible en: . https://www.rheumatology.org/Practice/Clinical/Position/Position_Statements/.
42. Danese S., Gomollon F. ECCO position statement: The use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). J Crohns Colitis. 2013, 7:586-589.
43. Covic A., Cannata-Andia J., Cancarini G., Coppo R., Frazão J.M., Goldsmith D., et al. Biosimilars and biopharmaceuticals: What the nephrologists need to know-a position paper by the ERA-EDTA Council. Nephrol Dial Transplant. 2008, 23:3731-3737.
44. Argüelles-Arias F., Barreiro-de-Acosta M., Carballo F., Hinojosa J., Tejerina T.I. Posición conjunta de la Sociedad Española de Patología Digestiva y la sociedad Española de Farmacología sobre el tratamiento con biosimilares en la enfermedad inflamatoria intestinal. Rev Esp Enferm Dig. 2013, 105:37-43.
45. EBE Position paper on labelling of biosimilars [consultado 1 Sep 2014]. Disponible en: . http://www.ebe-biopharma.eu/uploads/Modules/Documents/ebe-position-paper-labelling_3-07-2013.pdf.
46. AIFA Position Paper I farmaci Bisoimilari [consultado 1 Sep 2014]. Disponible en: . http://www.agenziafarmaco.gov.it/sites/default/files/AIFA_POSITION_PAPER_FARMACI_BIOSIMILARI.pdf.
47. ABPI position on Biosimimilars medicines [consultado 1 Sep 2014]. Disponible en: . http://www.abpi.org.uk/our-work/library/Documents/ABPI%20position%20on%20biosimilar%20medicines.pdf.
48. Feagan B.G., Choquette D., Ghosh S., Gladman D.D., Ho V., Meilbohm B., et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals. 2014, 42:177-183.
49. Lee H. Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars?. AAPS J. 2014, 16:22-26.
50. Ebbers H.C. Biosimilars: In support of extrapolation on indications. J Crohns Colitis. 2014, 8:431-435.
51. Elgert K. Antibody structure and function. En: Immunology: Understanding the Immune System 1998, 58-76. Wileyand Sons, Hoboken, New Jersey, Disponible en: http://www.wiley.com/legacy/products/subject/life/elgert/CH04.pdf [consultado 1 Sep 2014]. 2nd edition.
52. Breedveld F. Therapeutic monoclonal antibodies. Lancet. 2000, 355:735-740.
53. Jefferis R. Recombinant antibody therapeutics: the impact of glycosylation on mechanisms of action. Trends Pharmacol Sci. 2009, 30:356-362.
54. Schneider C.K. Biosimilars in rheumatology: The wind of change. Ann Rheum Dis. 2013, 72:315-318.
55. Disponible en: [consultado 1 Sep 2014]. http://www.fda.gov/drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122879.htm.
56. Disponible en: [consultado 1 Sep 2014]. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000901/wapp/Initial_authorisation/human_wapp_000034.jsp.
57. Disponible en: [consultado 1 Sep 2014]. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000603/wapp/Post-authorisation/human_wapp_000166.jsp%26mid=WC0b01ac058001d128.
58. Disponible en: [consultado 1 Sep 2014]. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001069/wapp/Initial_authorisation/human_wapp_000030.jsp%26mid=WC0b01ac058001d128.
59. Disponible en: [consultado 1 Sep 2014]. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000931/wapp/Initial_authorisation/human_wapp_000043.jsp%26mid=WC0b01ac058001d128.
60. Guidance For Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs) [consultado 8 Sep 2014]. Disponible en: . http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/brgtherap/applic-demande/guides/seb-pbu/seb-pbu-2010-eng.pdf.
61. Kaymakcalan Z., Sakorafas P., Bose S., Scesney S., Xiong L., Hanzatian D.K., et al. Comparisons of affinities, avidities, and complement activation of adalimumab, infliximab, and etanercept in binding to soluble and membrane tumor necrosis factor. Clin Immunol. 2009, 131:308-316.
62. Mitoma H., Horiuchi T., Tsukamoto H., Tamimoto Y., Kimoto Y., Uchino A., et al. Mechanisms for cytotoxic effects of anti-tumor necrosis factor agents on transmembrane tumor necrosis factor alpha-expressing cells: Comparison among infliximab, etanercept, and adalimumab. Arthritis Rheum. 2008, 58:1248-1257.
63. Tilg H., Moschen A., Kaser A. Mode of function of biological anti-TNF agents in the treatment of inflammatory bowel diseases. Expert Opin Biol Ther. 2007, 7:1051-1059.
64. Yoo D.H., 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, 72:1613-1620.
65. 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, 72:1605-1612.
66. Summary Basis of Decision for Remsima [consultado 5 Sep 2014]. Disponible en: . http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_remsima_160195-eng.php.
67. What you Need to Know about Biosimilar Medicinal Products [consultado 8 Sep 2014]. Disponible en: . http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_report_en.pdf.
68. Kay, Feagan B.G., Guirguis M.S., Keystone E.C., Klein A.V., Lubiniecki A.S., et al. Health Canada/BIOTECanada Summit on regulatory and clinical topics related to subsequent entry biologics (biosimilars), Ottawa, Canada. Biologicals. 2012, 40:517-527.
69. Scott B.J., Klein A.V., 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-S132.
70. Ebbers HC1, Muenzberg M., Schellekens H. The safety of switching between therapeutic proteins. Expert Opin Biol Ther. 2012, 12:1473-1485.
71. Referencia medicamentos no sustituibles. Orden SCO/2874/2007, de 28 de septiembre.
72. Van Assche G., Vermeire S., Ballet V., Gabriels F., Noman M., D'Haens G., et al. Switch to adalimumab in patients with Crohn's disease controlled by maintenance infliximab: Prospective randomised SWITCH trial. Gut. 2012, 61:229-234.
73. 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 [consultado 8 Sep 2014]. Disponible en: . https://ww2.rheumatology.org/apps/MyAnnualMeeting/Abstract/39201.
74. 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 [consultado 8 Sep 2014]. Disponible en: . https://ww2.rheumatology.org/apps/MyAnnualMeeting/Abstract/39033.
75. The NOR-SWITCH Study [consultado 8 Sep 2014]. Disponible en: . https://clinicaltrials.gov/ct2/show/NCT02148640?term=INFLIXIMAB+BIOSIMILAR%26rank=1.
76. Ebbers H.C., Crow S.A., Vulto A.G., Schellekens H. Interchangeability, immunogenicity and biosimilars. Nat Biotechnol. 2012, 30:1186-1190.
77. European Medicines Agency. Volume 9. A of The Rules Governing Medicinal Products in the European Union. (EMA, London, 2008) [consultado 8 Sep 2014]. Disponible en: . http://ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9a_09-2008_en.pdf.
78. Porter S. Human immune response to recombinant human proteins. J Pharm Sci. 2001, 90:1-11.
79. Ryff J.C., Schellekens H. Immunogenicity of rDNA-derived pharmaceuticals. Trends Pharmacol Sci. 2002, 23:254-256.
80. Vincent F.B., Morand E.F., Murphy K., Mackay F., Mariette X., Marcelli C. Antidrug antibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralising agents in chronic inflammatory diseases: A real issue, a clinical perspective. Ann Rheum Dis. 2013, 72:165-178.
81. Garcês S., Demengeot J., Benito-Garcia E. The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: A systematic review of the literature with a meta-analysis. Ann Rheum Dis. 2013, 72:1947-1955.
82. Casadevall N., Mayeux P. Pure red-cell aplasia and recombinant erythropoietin. N Engl J Med 2002, 346:1585.
83. Jani M., Barton A., Warren R.B., Griffiths C.E., Chinoy H. The role of DMARDs in reducing the immunogenicity of TNF inhibitors in chronic inflammatory diseases. Rheumatology (Oxford). 2014, 53:213-222.
84. Biosimilares. Butlletí d'informació terapèutica 2008, 20:43-46.
85. Expert Committee on biologicals satandaridizatio. Genevva, 19 to 23 October 2009. Guidelines on evaluation of similar biotherapeutic products (SBPs) [consultado 8 Sep 2014]. Disponible en: . http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf.
86. Disponible en: [consultado 8 Sep 2014]. http://www.who.int/medicines/services/inn/bq_innproposal201407.pdf?ua=1.
87. Disponible en: [consultado 8 Sep 2014]. http://www.who.int/medicines/services/inn/58th_executive_summary.pdf?ua=1.