December Biosimilars Bulletin: Year-End Highlights

Friday December 22, 2023

As we approach the end of the year, we wanted to share a few highlights. This was an active year on the biosimilars front as the market continued to evolve with the launch of biosimilars in new therapeutic areas, giving even more patients access to these lower-cost safe and effective medications.

The Biosimilars Council was pleased to testify before Congress and highlight concerns about the sustainability of the biosimilar industry. Going into 2024, PBM legislation will continue to be a legislative priority for the Biosimilars Council. We will continue to advocate for reform and point to examples of perverse PBM practices that stand in the way of biosimilar adoption.

The Council made great progress in the states, where we advocated for inclusion of biosimilars in state laws that would otherwise prevent rapid adoption of biosimilars. This legislation was enacted in California, Colorado and Louisiana. Importantly, we also have made significant strides on educational efforts with state legislators to counter misconceptions that interchangeable biologics are in some way safer or better than biosimilars.

As we continue our biosimilars education efforts, we are pleased to share the launch of several new resources intended to set the record straight on interchangeability and increase awareness about this designation and its role in the pharmaceutical system. Housed on a dedicated page on the Council website, the resources include an FAQ, a blog, a fact sheet, infographics and key educational documents from the FDA and other important stakeholders. The website also has the Council’s statement and comment on the FDA’s Draft Guidance on Labeling for Biosimilar & Interchangeable Biosimilar Products. We hope you’ll check them out and share with your networks—and stay tuned for new resources being added in the new year.

Most importantly, we’re excited that biosimilars continue to expand patient access to care. As we move into 2024, we will continue to emphasize the value of and challenges facing biosimilar competition.

As always, AAM and the Biosimilars Council will be kicking off the year at our annual conference, Access! 2024, taking place February 5th through the 7th in Tampa, Florida. This will include important discussions about biosimilars that you will not want to miss. We are grateful for your engagement and support and are looking forward to working with you to continue to promote biosimilar adoption.

Happy New Year


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October 21–23, 2024 | Rockville, MD

GRx+Biosims™ 2024 is the leading regulatory science and policy event for the U.S. generics and biosimilars industry. Access the most recent information straight from experts at the Food and Drug Administration, grasp the latest policies shaping the industry, and acquire valuable insights to propel your professional development.