FDA: USP Has A Role In Biosimilars, But Not With Prescriptive Standards

An FDA official said the United States Pharmacopeia has a role in the biosimilars space but the agency worries that prescriptive USP monographs would clash with FDA approval standards and slow biosimilar innovation. In the same vein, the chief medical officer for the pure-play biosimilars company Coherus BioSciences said having to comply with USP standards, along with FDA standards, would pose a hurdle to biosimilar development, and could impede patient access. The statements come as the generic drug lobby takes...