FDA Publishes Draft Biosimilars Guidance

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The Biologics Price Competition and Innovation Act of 2009 created an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, a U.S. Food and Drug Administration (FDA)-licensed biological reference product.  On February 9, 2012, FDA published the first three in a series of highly anticipated draft guidance documents that describe the agency’s approach to making the determination that two biological products are “biosimilar” or “interchangeable.”  In this newsletter, we provide a summary of these guidance documents and discuss some of their implications.

On February 9, 2012, the U.S. Food and Drug Administration (FDA) published three draft guidance documents that begin to describe the agency’s interpretation of the biosimilar approval pathway created by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).  A biological product is “biosimilar” to an FDA-licensed biological (the “reference product”) if it is highly similar to the reference product notwithstanding minor differences in clinically inactive components, and there are no clinically meaningful differences between the products in terms of safety, purity and potency.  See BPCI Act § 7002(b)(3).

The draft guidance documents, “Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009,”  “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product,” and “Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product,” address a broad range of issues.  Following are some highlights from these documents.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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