It’s no secret that the US biosimilar industry has had a slow start in terms of uptake.  Although the Hatch-Waxman Act and the Biologic Price Competition and Innovation Act (BPCIA) established pathways to approval for both generic drugs and biosimilars, there is still much legislative work to be done in order to truly reap the benefits of biosimilars.

The Center for Biosimilars sat down with April Breyer Menon, an expert on biosimilar patent law and founder of April Breyer Consulting in Chicago, Illinois, to discuss potential legislation such as The Hatch-Waxman Integrity Act and the Stop Stalling Act that would address barriers to biosimilar market entry.

Listen to the podcast 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 ( 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 ( 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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