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U.S. FDA Approves Biosimilar to Etanercept

Reuters Staff  |  

(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.

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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.

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