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Sandoz’s Biosimilar Filing Is Culmination Of Paradigm Shift In FDA Drug Review

 
• By Sue Sutter

FDA clinical reviewers moved from traditional “new drug” review mode to determining the evidence needed to demonstrate a follow-on product is highly similar to the reference biologic, Sandoz exec says, describing firm’s interactions with FDA on its filgrastim 351(k) application.

Sandoz Inc.’s application for a biosimilar version of Amgen Inc.’s Neupogen (filgrastim) not only marks the first publicly disclosed filing under the 351(k) regulatory pathway, it reflects a paradigm shift in thinking among FDA drug review staff that bodes well for other follow-on products working their way through the pipeline.

During five years of interactions with FDA over the filgrastim application, Sandoz witnessed an evolution in the mindset of clinical...

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