Posted by Michael Wonder on 03 Aug 2022
Fresenius Kabi’s biologics license application for biosimilar candidate tocilizumab accepted for review by the FDA
1 August 2022 - Fresenius Kabi announced today that the U.S. FDA has accepted for review the company’s 351(k) biologics license application for MSB11456, a biosimilar candidate of Actemra (tocilizumab).
Fresenius Kabi’s submission for its tocilizumab biosimilar candidate includes analytical similarity and comprehensive clinical data.
