At the Association for Accessible Medicines’ GRx+Biosims meeting on Wednesday, we heard hints of a major announcement regarding biosimilar 351(k) application requirements. By the time FDA Commissioner Marty Makary, MD, MPH, left the stage, we knew that a new draft guidance would be announced in an HHS press conference that afternoon. Indeed, HHS Secretary Robert … Continue reading The Demise of the Comparative Efficacy Trial Requirement for Biosimilars