FDA has released draft guidance on the use of clinical pharmacology studies to determine if a proposed therapeutic biologic product is biosimilar to its reference product. The guidance pertains to products that require pharmacokinetic and pharmacodynamics data to demonstrate biosimilarity. The guidance addresses clinical pharmacology testing for biosimilar products, developing an appropriate clinical pharmacology database, and designing clinical trials.
The draft guidance is one in a series by FDA for the implementation of the Biologics Price Competition Act of 2009. FDA intends the guidance to “assist sponsors in designing clinical pharmacology studies that can support an application submitted under section 351(k) of the Public Health Service Act (PHS Act).” According to FDA, the guidance may also be helpful for the development of certain products under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.