fda committee recommends sandoz biosimilar for approval

the u.s. is inching closer to approving its first biosimilar.the fda&39s oncologic drugs advisory committee unanimously recommended the approval of sandoz&39 biosimilar that is comparable to amgen&39s neupogen. related pack expo east brings innovations for pharma manufacturing to philadelphia, feb 16 18 &raquo&quotwe are pleased with the odac&39s recommendation to approve our biosimilar filgrastim and we look forward to continuing to work with fda as it completes its review of our filing,&quot said mark mccamish, m.d., ph.d., head of global biopharmaceutical &amp oncology injectables development at sandoz, in a news release.the decision came after recent documents from fda reviewers decided that there are &quotno clinically meaningful difference&quot between amgen&39s neupogen, and sandoz&39s biosimilar version.if approved in the u.s., sandoz proposes to market the biosimilar under the name zarxio.the drug is used during chemotherapy to fight off infections.&nbsp

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fda committee recommends sandoz biosimilar for approval