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ClinicalTrials & Tribulations

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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Byline
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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Byline
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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