On August 1, 2022 Fresenius reported that 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) (Press release, Fresenius, AUG 1, 2022, View Source [SID1234617195]). 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.
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*Actemra is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.