Sandoz Steers Enbrel Biosimilar Away From Equivalence Quandary With Reanalysis

FDA says Sandoz's biosimilar is highly similar to Amgen's Enbrel after Sandoz answered question about data comparing it to US-approved product.

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Sandoz Inc. avoided a potentially damaging equivalence problem in its biosimilar Enbrel filing by demonstrating its intricate understanding of the molecule.

The result seemed to ease FDA reviewers' concerns as they determined that Sandoz's GP2015 product is highly similar to its reference product, Amgen Inc.'s tumor necrosis factor blocker Enbrel...

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