BIO Submits Comments on Clinical Pharmacology Data to Support Biosimilarity

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.”

BIO believes that clinical pharmacology studies are an essential part of the stepwise, “totality of evidence” approach to demonstrating biosimilarity between a proposed biosimilar product and its reference product, and as such, BIO greatly appreciates the Agency’s work to publish the Draft Guidance. There are, however, several aspects of the Draft Guidance for which BIO requests additional information or clarification.