BioCentury
ARTICLE | Politics & Policy

ACA ruling threatens biosimilars provisions

December 17, 2018 9:51 PM UTC

A federal district court ruling Friday that could strike down the entire Affordable Care Act threatens to unravel FDA's biosimilar approval pathway.

The Biologics Price Competition and Innovation Act (BPCIA) of 2009, which was included in the ACA, created a pathway for FDA to approve biosimilars. The BPCIA has the support of Republicans, who have said all along that they plan to leave the rules in place in an ACA repeal-and-replace scenario (see "Wake Me In November")...