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With the FDA's acceptance of its 351(k) application, Novartis unit Sandoz has moved closer to gaining the agency's approval to market a second biosimilar – this time, a version of Amgen's tumor necrosis factor alpha (TNF-alpha) inhibitor Enbrel (etanercept), which reported $9bn in global sales in 2014, with close to half of that coming from the U.S.
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