Key FDA Officials Signal Approach to Review of Biosimilar Products

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Agency Will Rely on a Risk-Based and “Totality of the Evidence” Standard

In an article published in yesterday’s New England Journal of Medicine (“NEJM”), several key officials with the Food and Drug Administration (“FDA”) outlined an approach to review and approval of biosimilars in the United States. While this approach does not represent the official position of the agency, it does signal how the agency will likely review applications for biosimilar products under the Biologics Price Competition and Innovation Act. That statute, which was adopted last year, authorized FDA for the first time to approve biosimilars pursuant to an abbreviated pathway where applicants may rely on FDA’s previous approval of a “reference product.”

Specifically, in a publication entitled “Developing the Nation’s Biosimilars Program” in the August 4, 2011 edition of the NEJM, Dr. Steven Kozlowski (Director, Office of Biotechnology Products), Dr. Janet Woodcock (Director, Center for Drug Evaluation and Research), Dr. Karen Midthun (Director, Center for Biologics Evaluation and Research), and Dr. Rachel Behrman Sherman (Associate Director for Medical Policy) make the following key observations:

(1) FDA must, as a matter of initial priority, develop scientific criteria to evaluate how similar a biosimilar must be to a reference product to be close enough for approval. This will be challenging since most biologic products are complex and can not be easily characterized.

(2) Given the complexity of biologics, a “one size fits all” approach will not work. Rather, depending on the particular product, FDA scientists will consider various types of information or the “totality of the evidence” to assess biosimilarity.

(3) A totality of the evidence approach contemplates the use of multiple, complementary methods that allow for the evaluation of more attributes of a product at greater sensitivity. The authors point out this strategy was used to support approval of generic enoxaparin.

(4) Under this approach, animal and clinical studies will “for the foreseeable future” be required for approval of protein biosimilars. But, the scope and extent of such studies may be reduced where detailed “fingerprint-like characterization” is utilized.

Please see full article below for more information.

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