Tocilizumab biosimilar candidate MSB 11456 receives positive CHMP opinion
Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, announced that the CHMP has adopted a positive opinion recommending the granting of a marketing authorization for its tocilizumab biosimilar candidate MSB 11456 referencing RoActemra (tocilizumab)
MSB 11456 becomes the first tocilizumab biosimilar candidate to be granted a positive opinion by the CHMP for the treatment of several autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis, cytokine release syndrome, as well as for COVID-19.
The positive opinion covers both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations which offer a comprehensive, alternative treatment solution for patients treated with tocilizumab.
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