U.S. FDA Approves Biosimilar to Etanercept

(Reuters)—The U.S. Food and Drug Administration on Tuesday approved Novartis AG’s biosimilar version of Amgen Inc.’s arthritis drug etanercept (Enbrel).

The FDA approved the drug, Erelzi, known also as etanercept-szzs, for multiple inflammatory conditions, including rheumatoid arthritis and plaque psoriasis, a skin condition.

The agency approved the drug as a biosimilar, meaning there is no clinically meaningful differences between Erelzi and Enbrel. However, the two drugs are not considered interchangeable and are, therefore, not called generics.

The FDA’s ruling followed a unanimous vote by the agency’s advisory panel in July in favor of approval.