Biosimilars Access and Affordability Act

The Biosimilars Access and Affordability Act (S5571) was introduced in the 119th Congress by Sen. Marsha Blackburn (R-TN) on September 28, 2026, and read twice before being referred to the Committee on Finance. The bill is in early legislative stage with no further action yet. Its title suggests it aims to increase patient access to and affordability of biosimilar drugs, which are lower-cost alternatives to brand-name biologics. The referral to the Finance Committee indicates that the bill likely includes Medicare or Medicaid provisions, as the committee has jurisdiction over those programs.

The bill does not authorize any specific funding amount; instead, it would achieve its goals through regulatory and reimbursement changes. The primary mechanism is expected to involve closing the 'patent thicket' loophole that allows biologic manufacturers to list multiple patents to delay biosimilar entry, and potentially modifying Medicare Part D or Part B reimbursement to favor biosimilar dispensing. These changes would not directly allocate money but would shift market dynamics, potentially reducing federal spending on prescription drugs over time.

No related signals or procurement actions are currently available to provide convergence context. The bill stands alone as a legislative effort to promote biosimilar competition.

Structural winners include biosimilar manufacturers such as Novartis ($NVS) through its Sandoz division, Pfizer ($PFE) with its growing biosimilar portfolio, and other developers who would benefit from faster market entry and increased substitution rates. Structural losers include reference biologic manufacturers like AbbVie ($ABBV), whose Humira franchise faces accelerated revenue erosion from biosimilar competition. The impact on diversified pharmaceutical companies with both reference and biosimilar products (e.g., Amgen) is mixed and depends on portfolio balance.

The bill faces a long legislative path. It must be marked up by the Finance Committee, pass the full Senate, and then be considered by the House. Given the early stage and the typical timeline for healthcare legislation, enactment is unlikely before 2027 unless it gains significant bipartisan momentum. Investors should monitor committee hearings and potential companion bills in the House.