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FDA approves Amgen’s Humira biosimilar
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The U.S. Food and Drug Administration has approved Amgen Inc's biosimilar version of AbbVie's Humira (adalimumab).
Amjevita (adalimumab-atto) is approved to treat seven inflammatory diseases, including Crohn's disease, rheumatoid arthritis, psoriatic arthritis, psoriasis, and ulcerative colitis. Amjevita is Amgen's first biosimilar to receive regulatory approval.
The drug is the fourth FDA-approved biosimilar and is also undergoing review by the European Medicines Agency, following a regulatory application submitted in December 2015.
AbbVie has sued Amgen for patient infringement, claiming Amgen's biosimilar violates 10 patents. Amgen could take Amjevita to market before the patent dispute is resolved, but would risk paying damages if the court rules in favor of AbbVie. -by Rebecca Zumoff