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FDA draft guidance removes redundant PK testing requirements where scientifically rigorous data already exists.
Biosimilars Council
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.
