MSB 11456 (tocilizumab biosimilar) is filed at EMA in both intravenous and subcutaneous routes of administration .- Fresenius Kabi
Fresenius Kabi’s MAA submission for its tocilizumab biosimilar candidate of RoActemra includes comprehensive analytical, non-clinical and clinical similarity data. The clinical development program was established to demonstrate similar pharmacokinetic, pharmacodynamic, efficacy, safety, tolerability, and immunogenicity to the reference product and includes also switch data from RoActemra to MSB 11456. The MAA includes clinical data for both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations.
These two presentations offer a comprehensive, alternative solution for patients treated with tocilizumab. This submission represents Fresenius Kabi's third biosimilar candidate submitted in the European Union..
Learning Zones
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