Comment on “The End of Phase 3 Clinical Trials in Biosimilars Development?”
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I agree with the prediction of Dr Frapaise in his manuscript The End of Phase 3 Clinical Trials in Biosimilars Development?  that a robust chemistry, manufacturing, and controls (CMC) package will obviate the need for powered clinical efficacy studies; I also applaud the comments made by Christopher J. Webster and Gillian R. Woollett on Dr Frapaise’s article . I wish to provide additional clarification to make Dr Frapaise’s argument and the Webster and Woolett suggestions more relevant, based on my recent publications [3, 4, 5] and filing a Citizen Petition  against the FDA to change the regulatory guidance. My pivotal suggestion to the FDA was to waive clinical efficacy studies on the ground of their irrelevance, as suggested by Dr Frapaise. My Citizen Petition, along with comments made by other developers, resulted in the FDA withdrawing its pivotal guidance , and issuing a Biosimilars Action Plan (BAP) [8, 9] to carve out new regulatory guidance for...
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No funding was received.
Conflict of interest
Sarfaraz K. Niazi has no conflicts of interest.
- 3.Niazi S. Obstacles to success for biosimilars in the US market. Posted 4 January 2018. https://www.europeanpharmaceuticalreview.com/article/70987/obstacles-success-biosimilars-us-market/. Accessed 20 Dec 2018.
- 4.Niazi S. Rationalizing FDA guidance on biosimilars—expediting approvals and acceptance. 23 July 2018. http://gabi-journal.net/rationalizing-fda-guidance-on-biosimilars-expediting-approvals-and-acceptance.html. Accessed 20 Dec 2018.
- 5.Niazi, S. e-Book Challenges Facing Biosimilars Entries into US Markets. https://bioprocessintl.com/manufacturing/biosimilars/ebook-challenges-facing-biosimilar-products-us-markets/. Accessed 20 Dec 2018.
- 6.FDA: Citizen Petition by Sarfaraz Niazi and additional postings by the FDA. https://www.regulations.gov/docket?D=FDA-2018-P-1876. Accessed 20 Dec 2018.
- 7.FDA: Withdrawn Guidance: Statistical Approaches to Evaluate Analytical Similarity Guidance for Industry. https://www.pbwt.com/content/uploads/2018/06/UCM576786.pdf. Accessed 20 Dec 2018.
- 8.Scientist Invented A New Pathway To Approve Biosimilars, And The FDA Is Listening. Forbes Magazine 25 July 2018; https://www.forbes.com/sites/nicolefisher/2018/07/25/one-mans-mission-to-fix-the-fdas-biosimilar-problem/#56122f9d2380. Accessed 20 Dec 2018.
- 9.FDA: Biosimilars Action Plan (BAP) issued 1 July 2018; https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM613761.pdf. Accessed 20 Dec 2018.
- 10.Amgen Biosimilars. Clinical data. https://www.amgenbiosimilars.com/expertise/clinical-testing/. Accessed 20 Dec 2018.
- 11.ICH E6 guideline for good clinical practice: a trial should be initiated and continued only if the anticipated benefits justify the risks. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf. Accessed 20 Dec 2018.
- 12.US: Public Law 98-417. https://www.gpo.gov/fdsys/pkg/STATUTE-98/pdf/STATUTE-98-Pg1585.pdf. Accessed 20 Dec 2018.
- 13.The Biologics Price Competition and Innovation Act of 2009, (BPCIA), 42 USC 262(k). https://www.fda.gov/downloads/drugs/ucm216146.pdf. Accessed 20 Dec 2018.
- 14.FDA: Biosimilar Approval Pathway; https://www.fda.gov/downloads/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/PharmacyStudentExperientialProgramCDER/UCM587522.pdf. Accessed 20 Dec 2018.
- 15.US Title 21CFR320.22, Criteria for waiver of evidence of in vivo bioavailability or bioequivalence. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=320.22. Accessed 20 Dec 2018.
- 18.FDA: Approved Biosimilars; https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm580432.htm. Accessed 20 Dec 2018.
- 19.FDA’s Leah Christl Provides an Agency Perspective on the Biosimilars Landscape. https://www.centerforbiosimilars.com/conferences/alliance-for-patient-access-2018/fdas-leah-christl-provides-an-agency-perspective-on-the-biosimilars-landscape. Accessed 20 Dec 2018.
- 20.Dunn, A. FDA’s Woodcock: ‘The clinical trial system is broken’ https://www.biopharmadive.com/news/fdas-woodcock-the-clinical-trial-system-is-broken/542698/. Accessed 20 Dec 2018.