Division of Amgen Inc.
Latest From Immunex Corp.
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.
The FDA has approved Samsung Bioepis’ Eticovo as the second biosimilar competitor to Amgen’s blockbuster rheumatoid arthritis biologic Enbrel. Amgen immediately sued for patent infringement.
Although Samsung has not provided 180-day advance notice of commercialization for Eticovo, its recently approved biosimilar to Enbrel, Amgen seeks a preliminary injunction because it has reason to believe the company is prepared to launch ‘imminently.’
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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