Biosimilars May Be at Risk Depending on Court’s ACA Ruling

As the Supreme Court decides on the fate of the Affordable Care Act (ACA), much of the focus understandably has been on the millions of people who would lose health insurance coverage and protections for pre-existing conditions if the law is overturned. Another not-so-often-discussed ramification of such a ruling is that the biosimilars market could be completely upended. While industry experts tell AIS Health that such an outcome probably will not occur, they still recommend that stakeholders prepare for this possibility.

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created the 351(k) biosimilar pathway. After more than one attempt to get a stand-alone bill to pass, lawmakers made it part of the ACA, and it became law on March 23, 2010 (RSP 4/10, p. 1).

© 2024 MMIT
Angela Maas

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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