# Langworthy Introduces Biosimilar Access Bill

On October 2, 2026, Rep. Nick Langworthy introduced the bipartisan Biosimilars Access and Affordability Act, which would clarify when Medicare may temporarily delay price negotiation as a lower-cost biosimilar approaches the market. The proposal retains the existing maximum two-year delay, establishes clearer eligibility and manufacturer-certification rules, and would require rebates if the expected biosimilar does not reach patients. It is a proposed legislative change—not a contract opportunity or current compliance requirement—and could affect pharmaceutical manufacturers’ biosimilar development, market-entry, and Medicare access planning if enacted.

- Biosimilar manufacturers and organizations supporting their development should assess how the proposed certification and market-entry provisions could affect product timelines and Medicare negotiation exposure.
- The proposed rebate provision makes patient availability a consequential factor in using the delay; manufacturers should account for that risk in market-access planning.
- The bill does not identify a solicitation, award, or direct government purchasing opportunity. Procurement teams should treat it as a potential policy change rather than an active procurement requirement.

**Jurisdictions:** federal
**Industries:** Healthcare
**Topics:** Policy
**Published:** October 02, 2026

### Government Entities
- U.S. House of Representatives (House)
- Medicare
- U.S. Food and Drug Administration (FDA)

### Key Quotes
> Our legislation takes a straightforward approach that if a biosimilar is genuinely moving through the FDA process and toward the market, it should have a fair opportunity to compete.
> — Nick Langworthy, Congressman

> But unclear rules around Medicare's biosimilar delay provision are discouraging the investment needed to bring these treatments to market.
> — Casey McPherson, Executive Director of the Alliance for Patient Access

> Biosimilars have cut biologic prices by up to 85 percent, yet only a small fraction of name-brand biologics have biosimilars in development.
> — Scott Peters, Representative

### Sources
- [Congressman Langworthy Introduces Bipartisan Biosimilars Access & Affordability Act | Congressman Nick Langworthy](https://langworthy.house.gov/media/press-releases/congressman-langworthy-introduces-bipartisan-biosimilars-access-affordability) - Langworthy