Annals of Unintended Consequences: How FDA regulations undermine the biosimilar marketplace and the BPCIA

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In March 2010, as part of Affordable Care Act, Congress passed a well-conceived and critical legislative bill, the Biologic Pricing and Competition Innovation Act of 2009 (BPCIA)i. Despite its intentions, BPCIA has been instituted so that it complicates prescribing while increasing health care costs and reducing competition, rather than resulting in the anticipated benefits.

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Howard S. Hochster, MD
Distinguished Professor of Medicine; Associate director for clinical research and director, GI Oncology; Rutgers Cancer Institute; Director of oncology research, RWJBarnabas Health
Michael P. Kane, RPh, BCOP
Executive director, Oncology Pharmacy Services & Research Shared Resource, Rutgers Cancer Institute
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Last week, FDA granted accelerated approval to Replimune Group Inc. for it’s biologic, RP1 (vusolimogene oderparepvec), following the FDA Cellular, Tissue, and Gene Therapies Advisory Committee’s 10:3 vote in support of the biologic in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.
FDA has granted an accelerated approval to RP1 (vusolimogene oderparepvec) following the agency’s Cellular, Tissue, and Gene Therapies Advisory Committee’s 10:3 vote in support of the biologic in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.
Howard S. Hochster, MD
Distinguished Professor of Medicine; Associate director for clinical research and director, GI Oncology; Rutgers Cancer Institute; Director of oncology research, RWJBarnabas Health
Michael P. Kane, RPh, BCOP
Executive director, Oncology Pharmacy Services & Research Shared Resource, Rutgers Cancer Institute

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