AAM comments on Amneal's U.S. expansion of end-to-end biosimilars development with their acquisition of Kashiv BioSciences
Adds Chicago research and development facility, New Jersey manufacturing site
Adds Chicago research and development facility, New Jersey manufacturing site
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.
39 Groups support the Biosimilar Red Tape Elimination Act.
Matrix Global Advisors report highlights current barriers and recommendations for robust competition and patient savings in the next decade.