- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
AAM's Craig Burton: Is the Biden Administration Doing Enough to Help Biosimilars?
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.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
Experts Pressure Congress to Remove Roadblocks for Biosimilars
April 12th 2025Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.
