USP weighs in on biosimilarity

The U.S. Pharmacopeial Convention said its quality standards "may be helpful for informing FDA's evaluation" of the similarity between a proposed biosimilar and its reference product. The remark came in USP's (see BioCentury Extra, May 13).

USP is a nonprofit body that sets standards for the identity, strength, quality and purity of medicines and is a member of a council that negotiates non-proprietary names with manufacturers. ...