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April Breyer Menon Discusses 2 Potential Bills to Aid Biosimilar Uptake
April Breyer Menon, an expert on biosimilar patent law and founder of April Breyer Consulting in Chicago, Illinois, discussed 2 pieces of legislation that have the potential to address barriers to biosimilar market entry including the Hatch-Waxman Integrity Act and the Stop Stalling Act.
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.
To learn more about the Hatch-Waxman Integrity Act, visit click here.
To learn more about the Stop Stalling Act, visit click here.
Can Global Policies to Boost Biosimilar Adoption Work in the US?
November 17th 2024On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Biosimilars Gastroenterology Roundup for February 2023—Podcast Edition
March 5th 2023On this episode of Not So Different, we chronicle the latest gastroenterology news from February, including several updates on adalimumab and infliximab biosimilars and industry analyses on the utilization of these drugs and patient confidence in gastroenterologists’ recommendations.
