Boehringer Ingelheim receives EU approval for biosimilar Cyltezo

Boehringer Ingelheim has announced that Cyltezo, its new biosimilar version of adalimumab, has been approved by the European Commission.

The regulator has granted marketing authorisation to Cyltezo for the treatment of multiple chronic inflammatory diseases in adults and children, including rheumatoid arthritis, psoriatic arthritis, Crohn's disease, ankylosing spondylitis and ulcerative colitis.

This new biosimilar is based on AbbVie's Humira, with numerous analytical, pharmacological, non-clinical and clinical analyses having demonstrated the biosimilarity of Cyltezo to Humira.

For example, results from the pivotal phase III study VOLTAIRE-RA demonstrated clinical equivalence in the efficacy of the new drug to the reference product in patients with moderate to severely active rheumatoid arthritis.

Ivan Blanarik, senior vice-president and head of biosimilars at Boehringer Ingelheim, said: "Boehringer Ingelheim has been an industry leader in the production of biologics for 35 years, and we are delighted to have applied this expertise to the development of Cyltezo."

The company is also currently working to develop BI 695502, a bevacizumab biosimilar candidate based on the licensed therapy Avastin.

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