A comprehensive study of Regulatory compliance for Biosimilars in US, EU and India

  • Anshul Bansal
  • Vikesh Kumar Shukla
  • Shikha Chauhan

Abstract

The biopharmaceutical industry has gained significant interest in the last decade as the numbers of blockbuster biologic products are losing their patent rights. The regulatory authority is also providing marketing approval for Biosimilar products. Biological medicines are biotechnology developed drugs having large molecule which is complex in nature and are very sensitive to manufacturing conditions and parameters. Even a minor change in manufacturing conditions alters the quality and safety aspects of end product owing to increased risk for immune response. Biopharmaceutical companies use information technology such as molecular modelling and statistical data for drug development. Biosimilar drugs have moderate marketing cost which is alluring and generally 40 to 50 % less to that of originator drug product. Biosimilars are also known as “follow on biologics” or “similar biologics”. The following points needs consideration such as global harmonization, extrapolation studies, interchangeability study, long term post marketing studies to gain physician confidence in biosimilars.

Keywords: Biopharmaceuticals, Biosimilars, United states Food and Drug Administration, Biologics Licence Application (BLA), European Medical Agency (EMA)

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References

1. K.Raju MM. Biosimilar current status in India. Asian J Pharm Clin Res. 2017;10(1).
2. Vivek S. Biosimilars Market Overview [Internet]. Allied market research; 2015[Cited 2019 Feb 11]. Available from:
https://www.alliedmarketresearch.com/global-biosimilars-market.
3. Meenakshi KC. MS. Regulatory guidelines for approval of biosimilars in India, Europe, Brazil And China: a comprehensive overview. Int J Pharm Pharm Sci [Internet]. 2016[Cited 2019 Feb 20]; 08(10):7–11. Available from:
https://www.researchgate.net/publication/311671524_Regulatory_guidelines_for_approval_of_biosimilars_in_India_Europe_Brazil_and_China_A_comprehensive_overview,.
4. Hasumati R, C.C.Hacer SS. Quality, Non clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines. Front Pharmacol [Internet]. Semanticscholar; 2018[Cited 2019 Feb 24]. Available from:
https://pdfs.semanticscholar.org/2eee/9ca3c46685a650179e8c936e53d1ebefcc0f.pdf?_ga=2.125767178.1066019640.1560148920-1306289565.1549885873,
5. Rushvi P, Charmy K, C.Nirav CN. Biosimilars: an Emerging Market Opportunities in India. Pharm Regul Aff Open Access [Internet]. 2016 [Cited 2019 Feb 25]. Available from:
https://www.omicsonline.org/open-access/ biosimilars-an-emerging-market-opportunities-in-india-2167-7689-1000165.php?aid=73729.
6. Sharmila RV, Mounica NVN, Anusha S, L. Evangeline M. N. Regulatory Requirements of ‘Similar Biologics’ For Marketing Authorization In India. Int J Drug Regul Aff [Internet]. Researchgate; 2017 [Cited 2019 Feb 25];5(1):20–4. Available from:
https://www.researchgate.net/publication/316021896_REGULATORY_REQUIREMENTS_OF_’SIMILAR_BIOLOGICS’_FOR_MARKETING_AUTHORIZATION_IN_INDIA.
7. Krishna U. Biogenerics or Biosimilars: An overview of the current situation in India. Int J Med Pharm Sci [Internet]. Researchgate; 2012[Cited 2019 Feb 27];01(07). Available from:
https://www.researchgate.net/publication/236894615_Biogenerics_or_Biosimilars_An_overview_of_the_current_situation_in_India.
8. CDSCO. Guidelines on Similar Biologic: Regulatory Requirements for Marketing Authorization in India [Internet].CDSCO;2016;[ Cited 2019 Feb 28] Available from:
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/biologicals/CDSCO-DBT2016.pdf.
9. Bobby G. Changes in Regulatory requirements for Biosimilar development in India [Internet]. Biosimilar Development; 2016[Cited 2019 Mar 02]. Available from:
https://www.biosimilardevelopment.com/doc/changes-in-regulatory-requirements-for-biosimilar-development-in-india-0001.
10. Pooja P, Harvinder P, Ankit S, J.Anamika SS. Current Scenario of Biosimilar. The Pharmajournal.com. 2018;7(7):188-93.
11. Research C for DE and, Research C for BE and. Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry [Internet]. FDA; 2019 [Cited 2019 Mar 08]. Available from:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-therapeutic-protein-biosimilars-comparative-analytical-assessment-and-other-quality.
12. Leala T. What’s New in US. Biosimilar-Land? [Internet]. Bio-Rad Laboratories [Internet]. biosimilardevelopment ;2018 [Cited 2019 Mar 09]. Available from:
https://www.biosimilardevelopment.com/doc/what-s-new-in-u-s-biosimilar-land-000.
13. Research C for DE and. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product [Internet]. USFDA;2015 [Cited 2019 Mar 10]. Available from:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/scientific-considerations-demonstrating-biosimilarity-reference-product.
14. Biosimilar Development Process [Internet]. USFDA [Cited 2019 Mar 15]. Available from:
https://www.fda.gov/media/113355/download.
15. USFDA. Biosimilars Action Plan: Balancing Innovation and Competition [Internet]. USFDA; 2018 [Cited 2019 Mar 16]. Available from:
https://www.fda.gov/media/114574/download.
16. US Food and Drug administration. Biosimilar Product Regulatory Review and Approval [Internet]. [Cited 2019 Mar 19]. Available from:
https://www.fda.gov/files/drugs/published/Biosimilar-Product-Regulatory-Review-and-Approval.pdf.
17. US.FDA, CDER C. Considerations in Demonstrating Interchangeability With a Reference Product [Internet]. USFDA; 2019 [Cited 2019 Mar 22]. Available from:
https://www.fda.gov/media/124907/download.
18. FDA. Prescribing Biosimilar and Interchangeable Products [Internet]. USFDA; 2017 Oct 23[Cited 2019 Mar 23]. Available from:
https://www.fda.gov/drugs/biosimilars/prescribing-biosimilar-and-interchangeable-products
19. US.FDA. Prescribing Biosimilar Products [Internet]. USFDA [Cited 2019 Mar 25]. Available from:
https://www.fda.gov/media/108103/download
20. Biosimilars in the EU [Internet]. EMA; 2017 Apr [Cited 2019 Mar 27]. Available from:
https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf.
21. EMA. Biosimilar medicines: marketing authorisation [Internet].EMA; 2019 [Cited 2019 Mar 31]. Available from:
https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/biosimilar-medicines-marketing-authorisation.
22. EMA. Guideline on comparability of biotechnology-derived medicinal products after a change in the manufacturing process [Internet]. EMA; 2007 [Cited 2019 Mar 31]. Available from:
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-comparability-biotechnology-derived-medicinal-products-after-change-manufacturing-process_en.pdf.
23. EMA. European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal products applications [Internet].. EMA; 2019 [Cited 2019 Apr 01]. Available from:
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-procedural-advice-users-centralised-procedure-similar-biological-medicinal_en-0.pdf.
24. EMA. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues [Internet]. EMA; 2014 [Cited 2019 Apr 03]. Available from:
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-2.pdf.
25. EMA. Guideline on Immunogenicity assessment of therapeutic proteins [Internet]. EMA; 2017 [Cited 2019 Apr 03]. Available from:
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-immunogenicity-assessment-therapeutic-proteins-revision-1_en.pdf.
26. EMA. Biosimilar medicines: Overview [Internet]. EMA [Cited 2019 April 08]. Available from:
https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview.
27. EMA. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1) [Internet]. EMA; 2014 [Cited 2019 Apr 10]. Available from:
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-0.pdf.
28. European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1) [Internet]. EMA; 2014 [Cited 2019 Apr 03]. Available from:
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-0.pdf.
29. Generics and Biosimilars Initative. Biosimilars approved in Europe [Internet]. EMA; 2018 [Cited 2019 April 11]. Available from:
http://gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe.
30. Generics and Biosimilars Initative. Biosimilars applications under review [Internet]. EMA;2019 [Cited on 2019 Apr 11]. Available from:
http://www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-January-2019.
31. Denise M. The Biosimilars Market [Internet]. Pharmavoice.com; 2019 [Cited 2019 Apr 15]. Available from:
https://www.pharmavoice.com/article/2019-05-biosimilars/.
32. R.G.Lauri, S.Laurie CL. The Brave New World of Biosimilars [Internet]. Medscape;2016 [Cited 2019 Apr 15]. Available from:
https://www.medscape.com/viewarticle/863411#vp_2.
33. Initative G and B. ‘Similar biologics’ approved and marketed in India [Internet]. Gabionline; 2018 [Cited 2019 Apr 16]. Available from:
http://www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India.
34. Alex B, Robinson C. Steps to Reducing Barriers to Biosimilars in the United States [Internet]. Matrix Global Advisor; 2018 [Cited 2019 Apr 23]. Available from:
https://www.boehringer-ingelheim.us/sites/us/files/ files/barrierstobiosimilars_september2018.pdf.
35. Anjan S. A SWOT Analysis Of The Biosimilars Market. Pharm Technol Aff [Internet]. Pharmatech.com; 2010 [Cited 2019 Apr 25]. 22(9). Available from:
http://www.pharmtech.com/swot-analysis-biosimilars-market.
36. Debashish K. Biosimilar strategic Outlook [Internet]. slideshare; 2013 Jul 28 [Cited 2019 Apr 25]. Available from:
https://www.slideshare.net/debashishkar7/indian-strategic-outlook-biosimilars.
37. Christopher JE, Riddhi M.Dbe D. Biosimilars and Emerging Markets: Historical and Bioethical Considerations [Internet]. J Clin Res Bioeth; 2015 [Cited 2019 Apr 27]. Available from:
https://www.longdom.org/open-access/biosimilars-and-emerging-markets-historical-and-bioethical-considerations-2155-9627-1000243.pdf.
38. Joshua C. What’s Holding Back Market Uptake Of Biosimilars? [Internet]. Forbes; 2018 Jun [Cited 2019 Apr 27]. Available from:
https://www.forbes.com/sites/joshuacohen/2018/06/20/whats-holding-back-market-uptake-of-biosimilars/#69e127da691a.
39. Ravi L. Overcoming the Barriers to Global Biosimilar adoption. Biosimolar development [Internet]. Biosimilar development; 2016 [Cited 2019 Apr 27]. Available from:
https://www.biosimilardevelopment.com/doc/overcoming-the-barriers-to-global-biosimilar-adoption-0001.
40. Emerging Trends of Biosimilars in India [Internet]. IBE Foundation [Cited on 2019 Apr 19]. Available from:
https://www.ibef.org/download/Biosimilars-in-India-30312.pdf.
41. Surge of Indian biosimilars market forecast in 2019 [Internet]. Pharmavoice; 2019 [Cited on 2019 Apr 19]. Available from:
https://www.pharmavoice.com/newsreleases/surge-indian-biosimilars-market-forecast-2019/.
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How to Cite
Bansal, A., V. K. Shukla, and S. Chauhan. “A Comprehensive Study of Regulatory Compliance for Biosimilars in US, EU and India”. International Journal of Drug Regulatory Affairs, Vol. 7, no. 2, June 2019, pp. 17-34, doi:https://doi.org/10.22270/ijdra.v7i2.313.