(Rockville, Md., August28, 2015) “This week, the U.S. Food and Drug Administration (FDA)published a draft guidance and a proposed rule on nonproprietary naming of allbiological products. While the U.S. biosimilar approval pathway is stillrelatively new, the U.S. Pharmacopeial Convention (USP) has been part of awell-established drug naming system, which has included biologics, and our rolein setting public standards for quality is well-recognized in Federal law. USPwill continue to play these roles as it has since the beginning of drugapproval and licensing laws in the U.S.
USP’s mission is to improve globalhealth through public standards that help ensure the quality, safety andbenefit of medicines. Public standards that ensure product quality andconsistency are a critical part of the overall safety net that protects ourmedicines and the patients who use them. A public quality standard allowsindependent determination that a product has been made according to regulatoryexpectations for identity, strength, quality and purity regardless of amanufacturer or manufacturing process. Ultimately, a public standard assurespractitioners and patients that a product is what its label says it is.USP’s approach todeveloping standards for drugs and biologics evolves over time as the therapeuticlandscape changes. Thus, USP continues to engage appropriate stakeholders,including FDA, in discussions that recognize the transforming nature oftherapeutics, the critical role of transparent and science-based publicstandards for quality, and drug naming systems. USP is currently reviewingFDA’s draft guidance and proposed rule and looks forward to engaging in adialogue with and providing comments to the Agency.”