April Breyer Menon Discusses 2 Potential Bills to Aid Biosimilar Uptake

It’s no secret that the US biosimilar industry has had a slow start in terms of uptake, but much of that setback is due to barriers caused by originator manufacturers taking advantage of current legislation. 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.

 

We 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.