Fresenius Kabi’s regulatory submission for tocilizumab biosimilar accepted for review by FDA

The U.S. Food and Drug Administration (FDA) has accepted for review Fresenius Kabi's Biologics License Application (BLA) for MSB11456, a biosimilar candidate of Actemra®*(tocilizumab). This is an important achievement in the development of Fresenius Kabi’s biosimilar pipeline in the US. The BLA includes presentations for both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations. 

*Actemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.