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.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
