Venable Fizpatrick partner Ha Kung Wong spoke with The Center for Biosimilars for an article about Amy Coney Barrett’s potential appointment to the Supreme Court and what it might mean for the Affordable Care Act (ACA) and the Biologics Price Competition and Innovation Act (BPCIA). If the ACA is found unconstitutional, it could mean the end of the BPCIA and the biosimilar approval pathway.
The article by The Center for Biosimilars can be viewed here.
Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.
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