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

The European Medicines Agency (EMA) has accepted for review Fresenius Kabi’s Marketing Authorization Application (MAA) for MSB11456, a biosimilar candidate of RoActemra®*(tocilizumab). This is an important achievement in the development of Fresenius Kabi’s biosimilar pipeline, representing the company’s third biosimilar candidate submitted in the European Union. The MAA includes clinical data for both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations. 

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