Biosimilar Red Tape Elimination Act (S.2305): weakening FDA regulatory standards for biosimilars, undermining physician confidence and jeopardizing patient health

Author(s): Michael S Reilly, Esq, Ralph D McKibbin, MD, FACP, FACG, AGAF, Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP, Andrew Spiegel, Esq

Introduction: In the US, some biosimilars that meet additional requirements may be approved as interchangeable products. This means they can undergo pharmacy-level substitution. An online webinar titled ‘Biosimilar Red Tape Elimination Act (S.2305): Weakening FDA Regulatory Standards for Biosimilars, Undermining Physician Confidence and Jeopardizing Patient Health’, was held to discuss its implications on medicines availability, safety […]

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