Legislative Streamlining for Biosimilar Development: Biosimilar Red Tape Elimination Act & Expedited Access to Biosimilars Act
Monday, November 2, 2026
3:45 p.m. - 4:45 p.m.
This session will examine bipartisan, bicameral legislation introduced in the 119th Congress to modernize biosimilar development pathways, further aligning regulatory requirements with current science. Panelists will discuss two key legislative proposals:
- The Biosimilar Red Tape Elimination Act, which would eliminate the statutory interchangeability designation, and
- Expedited Access to Biosimilars Act, which would reduce reliance on comparative efficacy studies where scientifically appropriate
The discussion will explore how these proposals align with evolving FDA policy, advances in regulatory science, and international regulatory trends, as well as their potential impact on development programs, regulatory requirements, competition, and patient access.
Jennifer Black, JD
Health Counsel, Subcommittee on Health, Minority Staff, House Committee on Energy and Commerce
Clare Paoletta
Professional Staff Member, Subcommittee on Health, Majority Staff, House Committee on Energy and Commerce
Moderator: Mark Ratner
Senior Vice President of Government, AAM
