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FDA Biosimilar Policy Continues To Evolve With Approval Of Sandoz Erelzi

Executive Summary

Third biosimilar approved in US brings another iteration of FDA thinking on labeling and naming; etanercept-szzs, which references Amgen's Enbrel, suggests agency might be backtracking on its suffix policy.

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Sandoz's request that US FDA remove psoriatic arthritis and plaque psoriasis indications from biosimilar's approved labeling appears aimed at defending against patent infringement claims brought by Amgen, legal experts say.

Erelzi's Disappearing Indications: Biosimilar Loses Two Of Enbrel's Labeling Claims

Sandoz's request that US FDA remove psoriatic arthritis and plaque psoriasis indications from biosimilar's approved labeling appears aimed at defending against patent infringement claims brought by Amgen, legal experts say.

Sandoz’s Erelzi: Biosimilar Pediatric Labeling Strayed From Enbrel

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