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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Court rejects Sandoz's arguments that patents covering Enbrel's active ingredient and method of manufacture are invalid; decision comes three years after FDA approved Sandoz's biosimilar.
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Novartis wants a federal judge to stop Amgen from terminating the companies' agreements around potential migraine blockbuster Aimovig, in which it claims to have invested $870m to date. Amgen wants to go to trial, letting a jury decide whether it can end the partnership – and win damages.