The FDA has concluded that Sandoz’s biosimilar GP2015 “is highly similar to US-licensed Enbrel…and that there are no clinically meaningful differences between GP2015 and Enbrel in terms of the safety, purity, and potency of the product.” However, Amgen has already sued Sandoz over infringing on Enbrel’s patents to try to stop the biosimilars from coming to market.

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