Amjevita, developed by Thousand Oaks, Calif.-based Amgen, is intended to treat a variety of inflammatory diseases, including rheumatoid arthritis, Crohn’s disease and plaque psoriasis.
In July, an advisory panel for the FDA voted 26-0 that Amjevita was highly similar in safety and efficacy to Humira and should be approved.
“This is the fourth FDA-approved biosimilar. The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions,” said Janet Woodcock, MD director of the FDA’s Center for Drug Evaluation and Research.
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