Is Extrapolation of Safety and Efficacy Data Possible?

Frontiers of Gastrointestinal Research

Volumn 34, Issue , 2015, Pages 107-112

  Ainsworth, Mark ^a  

^a Mental Health Center Glostrup   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; INFLIXIMAB;

ARTICLE; CLINICAL TRIAL (TOPIC); DRUG APPROVAL; DRUG DATABASE; DRUG EFFICACY; DRUG INDICATION; DRUG POTENCY; DRUG SAFETY; DRUG STRUCTURE; HUMAN; PRIORITY JOURNAL;

EID: 84937883151     PISSN: 03020665     EISSN: 16623754     Source Type: Book Series    
DOI: 10.1159/000381580     Document Type: Article

References (30)

1. Committee for Medicinal Products for Human Use (CHMP): Guideline on similar biological medicinal products. CHMP/437/04. 2005. http://www.ema. europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003517.pdf (accessed May 17, 2015).
2. World Health Organization, Expert Committee on Biological Sterilization: Guidelines on evaluation of similar biotherapeutic products (SBPs), 2009. http://www.who.int/biologicals/areas/biological-therapeutics/BIOTHERA PEUTICS-FOR-WEB-22APRIL2010. pdf (accessed May 17, 2015).
3. Tsiftsoglou AS, Ruiz S, Schneider CK: Development and regulation of biosimilars: current status and future challenges. BioDrugs 2013; 27: 203-211.
4. Committee for Medicinal Products for Human Use (CHMP): Guideline on similar biological medicinal products containing monoclonal antibodies-nonclinical and clinical issues. EMA/CHMP/BMWP/403543/2010. 2012. http://www. ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2012/06/WC500128686.pdf (accessed May 17, 2015).
5. Berkowitz SA, Engen JR, Mazzeo JR, Jones GB: Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars. Nat Rev Drug Discov 2012; 11: 527-540.
6. 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): Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. Draft guidance, 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/UCM291128. pdf (accessed May 17, 2015 ).
7. Wang YM, Chow AT: Development of biosimilars-pharmacokinetic and pharmacodynamic considerations. J Biopharm Stat 2010; 20: 46-61.
8. Committee for Medicinal Products for Human Use (CHMP): Assessment report: Inflectra. International non-proprietary name: Infliximab. Procedure No. EMEA/H/C/002778/0000. EMA/CHMP/589422/2013. 2013. http://www. ema.europa.eu/docs/en-GB/document-library/EPAR-Public-assessment-report/human/002778/WC500151490. pdf (accessed May 17, 2015).
9. Committee for Medicinal Products for Human Use (CHMP): Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. EMEA/CHMP/BMWP/42832/2005. 2006. http://www.ema. europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003920.pdf (accessed May 17, 2015).
10. McKeage K: A review of CT-P13: an infliximab biosimilar. BioDrugs 2014; 28: 313-321.
11. 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.
12. Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, et al: A randomised, double-blind, parallelgroup 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.
13. Danese S, Fiorino G, Michetti P: Viewpoint: knowledge and viewpoints on biosimilar monoclonal antibodies among members of the European Crohn's and Colitis Organization. J Crohns Colitis 2014; 8: 1548-1550.
14. 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.
15. Argüelles-Arias F, Barreiro-de-Acosta M, Carballo F, Hinojosa J, Tejerina T: Joint position statement by 'Sociedad Espana de Patología Digestiva (Spanish Society of Gastroenterology) and 'Sociada Espanola de Farmacologia' (Spanish Society of Pharmacology) on biosimilar therapy for inflammatory bowel disease. Rev Esp Enferm Dig (Madrid) 2013; 105: 37-32.
16. 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: 177-183.
17. Fiorino G, Girolomoni G, Lapadula G, Orlando A, Danese S, Olivieri I: 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: 751-755.
18. Lee H: Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars? AAPS J 2014; 16: 22-26.
19. Hlavaty T, Letkovsky J: Biosimilars in the therapy of inflammatory bowel diseases. Eur J Gastroenterol Hepatol 2014; 26: 581-587.
20. Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Giezen TJ, et al: Biosimilars: what clinicians should know. Blood 2012; 120: 5111-5117.
21. Gecse KB, Khanna R, van den Brink GR, Ponsioen CY, Löwenberg M, Jairath V, et al: Biosimilars in IBD: hope or expectation? Gut 2013; 62: 803-807.
22. Moum B, Lundin KE: Biotilsvarende legemidler ved inflammatorisk tarmsykdom. Tidsskr Nor Legeforen 2014; 134: 819-820.
23. Brodszky V, Baji P, Balogh O, Pentek 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(suppl 1):S65-S71.
24. 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.
25. Dranitsaris G, Dorward K, Hatzimichael E, Amir E: Clinical trial design in biosimilar drug development. Invest New Drugs 2013; 31: 479-487.
26. Committee for Medicinal Products for Human Use (CHMP): Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use, 2012. http://www.ema.europa. eu/docs/en-GB/document-library/Scientific-guideline/2012/06/WC500128688.pdf (accessed May 17, 2015).
27. Ebbers HC, Crow SA, Vulto AG, Schellekens H: Interchangeability, immunogenicity and biosimilars. Nat Biotechnol 2012; 30: 1186-1190.
28. Calvo B, Zuniga L: EU's new pharmacovigilance legislation: considerations for biosimilars. Drug Saf 2014; 37: 9-18.
29. Casadevall N, Edwards IR, Felix T, Graze PR, Litten JB, Strober BE, et al: Pharmacovigilance and biosimilars: considerations, needs and challenges. Expert Opin Biol Ther 2013; 13: 1039-1047.
30. Ramanan S, Grampp G: Drift, evolution, and divergence in biologics and biosimilars manufacturing. BioDrugs 2014; 28: 363-372.