Biosimilars Bulletin: March Recap

Wednesday May 8, 2024

Biosimilar Advocates – despite a presidential election and short Congressional calendar, the Biosimilars Council continues to advance awareness and policies to encourage greater biosimilar adoption. We were disappointed that Congress did not include PBM reform in the March spending package, but we remain committed to addressing PBM practices that undermine biosimilar adoption. To that end, we released our new analysis of IQVIA data revealing health plans and patients missed out on savings up to $6 billion as a result of rebate schemes. The report highlights the strategy created by PBMs to protect $2 billion in profits by suppressing adoption of lower-cost versions of the brand drug Humira®, which was once the best-selling drug in the world. As you all know, in the past year, multiple biosimilar alternatives to Humira® launched in the U.S., but despite price discounts of greater than 80 percent, biosimilar adoption has been disappointingly slow, achieving less than two percent market share. The IQVIA analysis shines a light on the perverse incentives causing this slow adoption, including continued PBM reliance on rebates and fees that are tied to brand drug high list prices, and PBM practice of rewarding their vertically-integrated in-house specialty pharmacy networks compared to independent specialty and retail pharmacies. The Council will work with its partners to amplify this most recent example of barriers to biosimilar adoption at the expense of patients, and urge Congress to enact legislation that will rein in these PBM abuses.

The Biosimilars Council was pleased to see the President’s budget include a proposal to remove the statutory distinction between biosimilars and interchangeable biologics. The distinction between interchangeable biologics and biosimilars is not supported by science and continues to permit brand misinformation. The proposal would reduce confusion and increase patient access to lower cost biosimilars. There is significant work needed to enact this proposal, but this is an important step forward. The Council looks forward to working with the administration and Congress to expand patient access to lower cost biosimilars.

In a win for patients, on the state front, Governor Andy Beshear signed Kentucky House Bill 220 into law on March 14, a bill which allows health plans to encourage greater adoption of lower-cost biosimilar medicines while preventing misuse of step-therapy protocols. The Council applauded the passage of this bill that will increase patient access to lower-cost biosimilar medicines. Kentucky is the latest state to update its laws to remove barriers to biosimilar adoption and encourage greater use of cost-saving biosimilars—Arkansas, California and Louisiana have already passed this pro-patient legislation championed by the Council.

Festival of Biologics. America's Most exciting Biologics Event. April 15–17, 2024 | San Diego Convention Center. Book Now.

And finally, later this month the Council heads to the West Coast for the annual Festival of Biologics. The Council will be participating in several sessions throughout the three-day event, which brings together leaders from across the biologics industry to showcase research, bridge the gap between academia and industry, and collaborate on challenges to improve patient health. I will be speaking on a session focusing on biosimilars in the midst of legislative and market turmoil, and look forward to hearing remarks from speakers throughout the event—it’s sure to be an informative event, and we look forward to seeing many of you all there!


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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.