Despite all the headlines, there's one aspect of the Supreme Court's decision on the constitutionality of the Affordable Care Act that didn't get much coverage. The court's approval of the entire act means that the Biologics Price Competition and Innovation Act of 2009 (BPCIA) within the law now goes into full effect. BPCIA sets out a regulatory and dispute resolution framework for follow-on biologics or biosimilars inspired by the one the Hatch-Waxman Act uses for small-molecule generics. But, the fundamental differences that exist between biological products (large molecule drugs) and small molecule drugs and the process for approval and dispute resolution under the BPCIA means that reference product sponsors and biosimilar manufacturers will find themselves in uncharted and potentially time-consuming and costly waters.
Reprinted with permission from InsideCounsel.
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