The US FDA has released its biosimilars draft guidance on “Clinical Pharmacology” and this time the US regulator provides clarification on how it will evaluate applications by giving details about the comparative analytical characterization of the biosimilar product.
The new guideline is primarly focused on the pharmacokinetic and pharmacodynamic data which is needed to demonstrate biosimilarity.
The draft guidance is intended to assist sponsors with the design and use of clinical pharmacology studies to support a decision that a proposed therapeutic biological product is biosimilar to its reference product. Specifically, the guidance discusses some of the 23 overarching concepts related to clinical pharmacology testing for biosimilar products, approaches for developing the appropriate clinical pharmacology database, and the utility of modeling and simulation for designing clinical trials.
Once finalized, the guidance is intended to assist sponsors of biosimilar products in designing clinical pharmacology studies that can support an application submitted under section 351(k) of the Public Health Service Act (PHS Act). Some scientific principles described in the draft guidance may also be informative for the development of certain biological products under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), but no particular relationship between the standards for approval under these seperate statuory schemes is implied.
FDA mentions the importance of clinical pharmacology studies in the development of biosimilar products. These studies are part of a stepwise process for demonstrating biosimilarity between a proposed biosimilar product and the reference product and add to the totality of the evidence to support an overall demonstration of biosimilarity between the proposed biosimilar product and the reference product through the demonstration of no clinically meaningful differences. The guidance finally states that, data gathered from clinical pharmacology studies may also support a selective and targeted approach to the design of any necessary subsequent clinical studies to support a demonstration of biosimilarity.
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