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

display_title
fda committee recommends sandoz biosimilar for approval
 
If you would like to feature your company news, press releases, or other updates on our website, you can register and submit content directly through our platform or email us at info@packagingconnections.com.