Industry spars over FDA plan to cut comparative efficacy studies for biosimilars

Industry spars over FDA plan to cut comparative efficacy studies for biosimilars | RAPSRegulatory NewsJoanne S. EglovitchBiologics License Application (BLA)Biologics/ biosimilars/ vaccinesBiotechnologyChemistry, Manufacturing and Controls (CMC)GenericsProduct developmentRegulatory Intelligence/PolicyRegulatory strategyUnited StatesUS Food and Drug Administration (FDA)