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Novartis/Sandoz Biosimilar Erelzi OK'd; Covets Enbrel's US Sales

 
• By Donna Young

Novartis AG unit Sandoz Inc. won US approval of its biosimilar Erelzi, which is referenced on Amgen's tumor necrosis factor blocker Enbrel (etanercept). The product, however, currently is caught in a patent dispute, although a recent stipulation has provided some hope for a smoother path through the legal jungle than other biosimilars may face.

The expected FDA approval of Sandoz Inc.'s biosimilar version of Amgen Inc.'s tumor necrosis factor (TNF) blocker Enbrel (etanercept) came through on Aug. 30, bringing home the reality the latter firm could soon be facing competition for its $5bn in annual US sales once the new product is commercialized.

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