U.S. FDA approves Novartis biosimilar to Amgen's Enbrel

Last Updated: 2016-08-30

By Reuters Staff

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

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.