AAM urges reauthorization of FDA user fee programs
AAM and the Biosimilars Council say GDUFA IV and BsUFA IV can improve regulatory efficiency and support timely access to generic and biosimilar medicines.
Biosimilars Council
AAM and Biosimilars Council praise FDA plan to simplify biosimilar development
FDA draft guidance removes redundant PK testing requirements where scientifically rigorous data already exists.
Over 36 groups join the Biosimilars Council and AAM to reiterate support for interchangeability legislation
Call for passage of Biosimilar Red Tape Elimination Act.
AAM and the Biosimilars Council praise FDA announcement on biosimilars clinical efficacy studies and interchangeability
FDA Commissioner Makary joined AAM’s GRx+Biosims 2025 conference today.
