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Posted in News & Events

FDA’s Long-Awaited Biosimilars Guidances—The Prologue to Biosimilars in the U.S. has been published

The U.S. Food and Drug Administration released three draft Guidances on implementation of the Biologics Price Competition and Innovation Act of 2009. The Q&A, Scientific Considerations, and Quality Guidances cover the overall framework for biosimilar application requirements as envisioned by FDA. Notably, FDA has deferred guidance on how to establish interchangeability. FDA emphasizes a “step-wise”