Legislation codifies FDA's science-based approach to biosimilar review by limiting comparative efficacy studies; Introduced and passed House Committee this week.
Legislative progress codifies FDA's science-based approach to biosimilar review by limiting comparative efficacy studies; Eliminates arbitrary distinction between interchangeable biologics and biosimilars.
AAM thanked the Senate HELP Committee for advancing legislation and urged policymakers to focus on expanding patient access to affordable medicines.
“This decision will help enhance the generic medicines supply chain."
FDA draft guidance removes redundant PK testing requirements where scientifically rigorous data already exists.
Hoffman emphasized what he called a return to fundamentals for the industry, highlighting disciplined execution, competition, and collaboration as key to long-term sustainability.
Outlines four key policy areas Congress can act on now to protect generic and biosimilar medicines and provide access and savings for patients.
“It is an honor to serve as AAM board chair, and I thank the board for the privilege,” said Bob Hoffman.
Call for passage of Biosimilar Red Tape Elimination Act.
By John Murphy III, president and CEO of the Association for Accessible Medicines
Cuts red tape, brings patient faster access to lower-cost medicines.
FDA Commissioner Makary joined AAM’s GRx+Biosims 2025 conference today.
Generic pharmaceutical trade group steps in to protect patient access to affordable generic drugs.
AAM President John Murphy III noted that prices for generic and biosimilar medicines keep falling, yet no biosimilar for Enbrel is available in the U.S.
The bipartisan, bicameral legislation was included in the 2024 year-end spending bill and reintroduced in this Congress.
The Association for Accessible Medicines states that lower-cost drugs saved $3.4 trillion over the past decade but warns that regulatory and pricing pressures threaten the market's long-term viability.
