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.
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Drug Review Profile of TNF-inhibitor etanercept-szzs examines how US FDA navigated its way around ‘inaccurate’ pediatric psoriasis labeling for the reference product, Amgen’s Enbrel, to reflect current state of the knowledge on the biosimilar’s labeling, albeit only temporarily.
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.
For second time Sandoz faces claims it is trying to reap benefits of biosimilars law without meeting its obligations.