FDA Approves Biggest Biosimilar Yet

The third biosimilar to receive FDA approval is Novartis’ answer to Enbrel, Amgen’s blockbuster that sold $9.5 billion last year.

Sandoz / Photo: pharmaobserver.com
Sandoz / Photo: pharmaobserver.com

A recent FierceBiotech article discussed the FDA’s approval of the rheumatoid arthritis and psoriasis biosimilar to Enbrel. The drug will be marketed under the name Erelzi, and is the third biosimilar approved in the U.S. The first was Novartis’ Zarxio- rival to Amgen’s Neupogen. Novartis’ generic division, Sandoz, is planning three more FDA submissions for biosimilars in the next two years for Amgen’s Epogen, AbbVie’s Humira, and Roche’s Rituxan.

“The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases,” said Dr. Janet Woodcock,director of the FDA’s Center for Drug Evaluation and Research. Not to be outdone, Amgen is launching its own biosimilar strategy targeting Humira, but AbbVie is making its own legal patent case to defend it.

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