Biosimilars Access and Affordability Act

The Biosimilars Access and Affordability Act (HR10628) was introduced in the House on September 28, 2026, by Rep. Langworthy (R-NY) with eight bipartisan cosponsors. It was referred to two committees with jurisdiction over Medicare and tax policy. The bill amends Section 1192 of the Social Security Act to change the eligibility timeline for biosimilar biological products in Medicare's drug price negotiation program. Specifically, it adjusts the definition of 'selected drug' and the negotiation period, potentially allowing biosimilars to enter negotiations earlier than under current law. No funding is authorized; the bill is a regulatory change.

The money trail is indirect: the bill does not allocate funds but could alter Medicare spending by accelerating price negotiations for biosimilars, potentially lowering drug costs for the program. This would reduce revenue for originator biologic manufacturers while potentially increasing market access for biosimilar developers. The Congressional Budget Office would score any savings if the bill advances.

Structural winners include pure-play biosimilar companies like Coherus ($CHRS) and Viatris ($VTRS), which could see faster adoption of their products. Losers include large biologic manufacturers like Amgen ($AMGN) and Pfizer ($PFE), which face earlier revenue erosion from biosimilar competition. However, many large pharma companies also have biosimilar portfolios, creating offsetting effects.

The bill is in early stages; next steps include committee hearings, markup, and potential floor votes. Bipartisan support increases its chances, but the 119th Congress has limited time remaining. Investors should monitor committee activity for signs of momentum.