FDA Issues Biosimilars Guidance

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 01-05-2017 15:44


The US Food and Drug Administration (FDA) has issued final guidance,Clinical Pharmacology: Data to Support a Demonstration of Biosimilarity to a Reference Product, 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.

The guidance pertains to those products—such as therapeutic biological products—for which pharmacokinetic and pharmacodynamic data are needed to support a demonstration of biosimilarity. Specifically, the guidance discusses some of the 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.

This guidance is one in a series that the FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009, which provided a regulatory pathway in the US for biosimilars by establishing an abbreviated pathway for FDA licensure of biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-licensed reference product/p>

Source: FDA


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