The Language of Biosimilars: Clarification, Definitions, and Regulatory Aspects

Drugs

Volumn 77, Issue 6, 2017, Pages 671-677

  Declerck, Paul ^a   Danesi, Romano ^b   Petersel, Danielle ^c   Jacobs, Ira ^c  

^a UNIVERSITY OF LEUVEN   (Belgium)

^b UNIVERSITY OF PISA   (Italy)

^c PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT;

BIOLOGICAL THERAPY; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG SAFETY; HUMAN; REVIEW; STUDY DESIGN; AUTOIMMUNE DISEASES; LEGISLATION AND JURISPRUDENCE; NEOPLASMS; PROCEDURES;

AUTOIMMUNE DISEASES; BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; HUMANS; NEOPLASMS;

EID: 85014360186     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-017-0717-1     Document Type: Review

References (35)

1. World Health Organization. Guidelines on evaluation of similar biotherapeutic products (SBPs) Expert Committee on Biological Standardization, Geneva, Switzerland. 2009 (last update 23 Oct 2009). http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf Accessed 17 Mar 2016.
2. European Medicines Agency. Guideline on similar biological medicinal products (CHMP/437/04 Rev 1). European Medicines Agency, London. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf Accessed 11 May 2016.
3. European Medicines Agency. European public assessment reports by type (biosimilars). European Medicines Agency, London. 2016. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124&searchTab=searchByAuthType&keyword=Enter%20keywords&searchType=name&alreadyLoaded=true&status=Authorised&status=Withdrawn&status=Suspended&status=Refused&jsenabled=false&searchGenericType=biosimilars&orderBy=status&pageNo=1. Accessed 26 Apr 2016.
4. US Food and Drug Administration. FDA approves first biosimilar product Zarxio [media release]. US Department of Health and Human Services, Food and Drug Administration, Silver Spring, MD. 2015 (last update 6 Mar 2015). http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm. Accessed 11 May 2016.
5. Generics and Biosimilars Initiative (GaBi). US$67 billion worth of biosimilar patents expiring before 2020. Pro Pharma Communications International, Mol, Belgium. 2012 (last update 20 Jan 2014). http://www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020. Accessed 11 May 2016.
6. US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Silver Spring, MD. 2015. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291128.pdf. Accessed 20 May 2015.
7. Ventola CL. Evaluation of biosimilars for formulary inclusion: factors for consideration by P&T committees. P T. 2015;40:680–9.
8. Socinski MA, Curigliano G, Jacobs I, Gumbiner B, MacDonald J, Thomas D. Clinical considerations for the development of biosimilars in oncology. MAbs. 2015;7:286–93. doi:10.1080/19420862.2015.1008346.
9. Declerck P, Farouk-Rezk M, Rudd PM. Biosimilarity versus manufacturing change: two distinct concepts. Pharm Res. 2016;33:261–8. doi:10.1007/s11095-015-1790-3.
10. van Aerts LA, De Smet K, Reichmann G, van der Laan JW, Schneider CK. Biosimilars entering the clinic without animal studies. A paradigm shift in the European Union. MAbs. 2014;6:1155–62. doi:10.4161/mabs.29848.
11. Chapman K, Adjei A, Baldrick P, da Silva A, De Smet K, DiCicco R, et al. Waiving in vivo studies for monoclonal antibody biosimilar development: national and global challenges. MAbs. 2016;8:427–35. doi:10.1080/19420862.2016.1145331.
12. Isakov L, Jin B, Jacobs IA. Statistical primer on biosimilar clinical development. Am J Ther. 2016;23:e1903–10. doi:10.1097/MJT.0000000000000391.
13. US Food and Drug Administration. Guidance for industry: E9 statistical principles for clinical trials. US Department of Health and Human Services, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Rockville, MD. 1998 (last update September 1998). http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073137.pdf. Accessed 17 March 2016.
14. Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood. 2014;124:3191–6. doi:10.1182/blood-2014-06-583617.
15. Health Canada. Summary basis of decision (SBD) for Remsima. Office of Regulatory Affairs, Health Canada, Ottawa, Ontario, Canada. 2014 (last update Apr 2015). http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_remsima_160195-eng.php#sbd. Accessed 11 May 2016.
16. Health Canada. Summary basis of decision (SBD) for Inflectra. Office of Regulatory Affairs, Health Canada, Ottawa, Ontario, Canada. 2014 (last update 8 Jun 2015). http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_inflectra_159493-eng.php. Accessed 11 May 2016.
17. Health Canada. Regulatory decision summary for REMSIMA (Control number 184568). 2016. Available at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/rds-sdr/drug-med/rds-sdr-remsima-184568-eng.php. Accessed 10 Oct 2016.
18. Health Canada. Regulatory decision summary INFLECTRA. 2016. Available at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/rds-sdr/drug-med/rds-sdr-infectra-184564-eng.php. Accessed 10 Oct 2016.
19. US Food and Drug Administration. Considerations in demonstrating interchangeability with a reference product. Guidance for Industry. DRAFT GUIDANCE. 2017. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537135.pdf. Accessed 31 Jan 2017.
20. Tothfalusi L, Endrenyi L, Chow SC. Statistical and regulatory considerations in assessments of interchangeability of biological drug products. Eur J Health Econ. 2014;15(Suppl 1):S5–11. doi:10.1007/s10198-014-0589-1.
21. Declerck P, Mellstedt H, Danese S. Biosimilars—terms of use. Curr Med Res Opin. 2015;31:2325–30. doi:10.1185/03007995.2015.1098601.
22. Abraham J. Developing oncology biosimilars: an essential approach for the future. Semin Oncol. 2013;40(Suppl 1):S5–24. doi:10.1053/j.seminoncol.2013.09.015.
23. Christl L. FDA’s overview of the regulatory guidance for the development and approval of biosimilar products in the US. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM428732.pdf. Accessed 27 June 2016.
24. Mikhail A, Farouk M. Epoetin biosimilars in Europe: five years on. Adv Ther. 2013;30:28–40. doi:10.1007/s12325-012-0072-2.
25. European Medicines Agency. Retacrit: EPAR—Scientific Discussion. 2008. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000872/WC500054374.pdf. Accessed 11 Jan 2017.
26. 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;36:613–25. doi:10.1007/s00296-016-3444-0.
27. Castaneda-Hernandez G, Gonzalez-Ramirez R, Kay J, Scheinberg MA. Biosimilars in rheumatology: what the clinician should know. RMD Open. 2015;1:e000010. doi:10.1136/rmdopen-2014-000010.
28. Dorner T, Kay J. Biosimilars in rheumatology: current perspectives and lessons learnt. Nat Rev Rheumatol. 2015;11:713–24. doi:10.1038/nrrheum.2015.110.
29. US Food and Drug Administration. Guidance for Industry. Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Rockville, MD. 2005 (last update Jun 2005). http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073476.pdf Accessed 11 May 2016.
30. US Food and Drug Administration. Nonproprietary Naming of Biological Products. Guidance for Industry. 2017. http://www.fda.gov/downloads/drugs/guidances/ucm459987.pdf. Accessed 31 Jan 2017.
31. World Health Organization. Biological Qualifier An INN Proposal. 2015. http://www.who.int/medicines/services/inn/WHO_INN_BQ_proposal_2015.pdf. Accessed 7 Feb 2017.
32. Generics and Biosimilars Initiative (GaBi). EU majority says same INNs for biosimilars. 2014. http://www.gabionline.net/Biosimilars/General/EU-majority-says-same-INNs-for-biosimilars. Accessed 31 Jan 2017.
33. Danese S, Bonovas S, Peyrin-Biroulet L. Biosimilars in IBD: from theory to practice. Nat Rev Gastroenterol Hepatol. 2017;14:22–31. doi:10.1038/nrgastro.2016.155.
34. US Food and Drug Administration. Drugs@FDA Glossary of Terms. 2012. http://www.fda.gov/drugs/informationondrugs/ucm079436.htm#B. Accessed 18 July 2016.
35. Generics and Biosimilars Initiative (GaBi) Online. Small molecule versus biological drugs. 2012. http://www.gabionline.net/Biosimilars/Research/Small-molecule-versus-biological-drugs. Accessed 18 July 2016.