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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.
Biosimilars in Action: Market Shifts, Legal Insights, and FDA Approvals
February 9th 2025In this episode of Not So Different, host Skylar Jeremias covers the latest biosimilar developments, including new FDA approvals, patent disputes, and biosimilar market trends shaping the health care landscape.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
Biosimilars Policy Roundup for March 2023—Podcast Edition
April 2nd 2023On this episode of Not So Different, we discuss some of the global biosimilar policy news that came out during the month of March, including a new bill in Congress and 2 Canadian jurisdictions implementing switching policies.
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.
