Craig Burton, senior vice president of policy and strategic alliances at the Association for Accessible Medicines and executive director of the Biosimilars Council, gives insight into the many health policies that the Biden administration has implemented in 2022 as well as their possible impact on biosimilar adoption.
This year, the federal government in the United States has done a lot to get new policies passed that will improve biosimilar uptake and lower drug prices as a result. These actions include the implementation of the Biosimilars User Fee Act of 2022 (BsUFA III) and the Inflation Reduction Act, workshops and investigations, and a public commitment to investing in biotechnology. However, do all of these actions actually help biosimilars? Are there bad parts to any of them? And will they deliver on the bipartisan goal of lowering drug prices?
Today, I’m joined by Craig Burton, senior vice president of policy and strategic alliances at the Association for Accessible Medicines (AAM) and executive director of the Biosimilars Council. He has over 20 years of experience working with federal health policies and works closely with patient advocacy groups. Craig also served as the HHS deputy assistant director of legislation, health policy advisor to Senate Majority Leader Bill Frist, MD, and a professional staff member on the US Senate Committee on Health, Education, Labor and Pensions prior to joining the AAM and Biosimilars Council teams.
Show notes:
This episode is made in conjunction with the third annual Global Biosimilars Week, a biosimilar awareness campaign hosted by the International Generic and Biosimilar Association (IGBA) from November 14 through November 18. The Center for Biosimilars is a proud media partner for Global Biosimilars Week and you can check all our social media pages to view our coverage of the event.
To learn more about Global Biosimilars Week, click here.
To learn more about BsUFA III, click here.
To learn more about the Inflation Reduction Act, click here.
To learn more about President Biden’s executive order, click here.
To learn more about President Biden’s support for biotechnology, click here.
To learn more about efforts to investigate pharmacy benefit managers, click here.
To learn more about the FDA’s recent workshop, click here.
To learn more about the FDA’s updated guidance on interchangeability, click here.
To learn more about the approval of Cimerli, click here, and to learn more about the controversy surrounding it, click here.
Commercial Payer Coverage of Biosimilars: Market Share, Pricing, and Policy Shifts
December 4th 2024Researchers observe significant shifts in payer preferences for originator vs biosimilar products from 2017 to 2022, revealing growing payer interest in multiple product options, alongside the increasing market share of biosimilars, which contributed to notable reductions in both average sales prices and wholesale acquisition costs.
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.
The Rebate War: How Originator Companies Are Fighting Back Against Biosimilars
November 25th 2024Few biologics in the US have multiple biosimilar competitors, but originator biologics respond quickly to competition by increasing rebates and lowering net prices, despite short approval-to-launch timelines for biosimilars.
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.