German Humira Biosimilar for Inflammatory Diseases Cleared for EMA Approval

Cyltezo, an adalimumab biosimilar drug by Boehringer Ingelheim, has received the backing to be marketed in Europe.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended Cyltezo for approval, moving it closer to the market and offering a new treatment for a range of inflammatory diseases. The biosimilar drug of adalimumab (Humira) could treat a wide range of conditions in adults and certain pediatric inflammatory diseases, for example, Crohn’s disease, psoriasis, and arthritis.

Boehringer Ingelheim obtained the support thanks to impressive pre-clinical and clinical data supporting their candidate’s similarity to Humira. A final decision on Cyltezo’s approval from the EMA is expected by the end of the year.

Cyltezo inhibits tumor necrosis factor-ɑ (TNFɑ), which is a mediator of inflammation in autoimmune diseases. However, this approach comes with risks, for example, infection and cancer. Nevertheless, it enters a field that is already very busy. Humira, the top-selling biological of 2016, and Enbrel are two TNF-inhibitors that are already available on the market, and Sanofi and Regeneron have just seen their IL-6 inhibitor, sarilumab, approved by the FDA and EMA.

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