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FDA to Present Guidance on Interchangeability, Analytics for Biosimilars

September 14, 2016

The FDA intends to clarify its expectations for demonstrating the interchangeability of biosimilars with reference products, an FDA official said.

The agency plans to issue recommendations on statistical techniques for evaluating analytical similarity data as well, said Steven Kozlowski, director of CDER’s Office of Biotechnology Products, at the 2016 GPhA Biosimilars Council Conference.

These are just two of the tasks the FDA will undertake to address the murkier aspects of biosimilar development. Kozlowski noted that the agency also aims to host webinars and presentations at professional societies.

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