Biosimilars Clarity Coming as FDA Eyes Sandoz Application

Paul A. Calvo, Ph.D. was quoted in this IP Law360 article discussing the first biosimilar application to be accepted by the U.S. Food & Drug Administration (FDA) under the pathway created by the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The acceptance of the biosimilar application from Sandoz Inc. is expected to produce answers about how these products will be utilized in the American market. “”It’s the first step in actually seeing approval of a biosimilar in the US. I think the word ‘finally’ comes to mind,”” said Dr. Calvo.

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