U.S. bipartisan bills target Medicare biosimilar price negotiations

Bipartisan legislation has been introduced in the U.S. House and Senate to address biosimilar access and affordability. The proposed Biosimilars Access and Affordability Act would amend the Social Security Act to alter the timing of Medicare price negotiations for biologics that face competition from biosimilars.

Industry experts note that biosimilar dispensing rates fell by more than 40% between 2024 and 2025. This decline is attributed to pharmacy benefit manager (PBM) rebate structures, where higher-priced brand-name drugs can generate larger rebates than lower-cost biosimilar alternatives. This incentive structure often steers patients toward expensive branded competitors rather than cost-effective biosimilars.

While the FDA has issued guidance to reduce regulatory burdens and clinical study costs for biosimilar development, manufacturers face high risks, with development often costing up to $300 million and taking years to launch. Proponents suggest that increased support could significantly raise the savings provided by biosimilars to the healthcare system.