FDA, Senators Seek To Keep USP Standards From Hindering Biosimilar Development

A provision quietly tucked into the Senate health committee's counterpart to the House-passed 21st Century Cures legislation is aimed at addressing concerns that United States Pharmacopeia standards could delay licensure of biosimilar and interchangeable products. But USP does not agree, and told Inside Health Policy that FDA has not provided it with any examples of where a USP standard has gotten in the way of approval of a biological product. The provision also holds implications for FDA's naming policy. Under...