FDA Releases New Guidance for Biosimilar Applications

Yesterday, the U.S. Food and Drug Administration provided further clarity as to how it will evaluate applications for approval of biosimilars when it released a draft guidance document outlining the types of clinical pharmacology data it wants to see to support a finding that a therapeutic biological product is highly similar to a reference product. This most recent guidance document comes more than one year after the last guidance document from the FDA specifically addressing biosimilars, and continues the agency’s slow and cautious implementation of the Biologics Price Competition and Innovation Act that was enacted in March of 2010.

The guidance is focused primarily on the pharmacokinetic (PK) and pharmacodynamic (PD) data necessary to demonstrate biosimilarity. While the guidance is intended to assist biosimilar applicants in designing clinical pharmacology studies that can support an application submitted under 351(k), it is nonbinding and a biosimilar applicant may use an alternative approach to demonstrate biosimilarity provided it satisfies the requirements of the applicable statute and regulations. The FDA has established a 90-day period for public comment on the draft guidance.

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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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