Will Trump’s Election Impact the BPCIA?

BPCIA and Related U.S. Statutes

The election last night of Donald Trump as the next President of the United States may have far-reaching consequences on numerous legal and policy issues, including immigration, international trade, and health care. Although we are not aware of President-elect Trump ever directly mentioning biosimilars on the campaign trail, it is widely known that he favors repealing and replacing Obamacare.  What may be less widely known is that the Biologics Price Competition and Innovation Act (BPCIA) – the law that created the biosimilars pathway – was enacted as part of Obamacare (officially known as the Affordable Care Act).  Consequently, efforts to repeal and replace Obamacare could have a significant impact on the BPCIA.  Although we have no reason to believe lawmakers or President-elect Trump will intentionally seek to repeal the BPCIA, they may use legislation repealing Obamacare as an opportunity to open up and make revisions to the BPCIA.

We will closely monitor this situation and report on any legislative developments that may affect Obamacare and the BPCIA.

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