FDA Accepts for Review Fresenius Kabi’s BLA for Tocilizumab Biosimilar

On August 1, 2022, Fresenius Kabi announced that the FDA accepted for review its Biologics License Application (BLA) for MSB11456, a biosimilar candidate for ACTEMRA (tocilizumab).  The BLA includes both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations.  This is the first BLA accepted by FDA for a tocilizumab biosimilar.  In September 2021, Fresenius reported that its tocilizumab biosimilar successfully met the primary and secondary endpoints in two consecutively conducted clinical trials.