Boehringer Wins Europe’s First Biosimilar Approval

Boehringer Ingelheim has been granted its first biosimilar approval in Europe, receiving  authorization to market Cyltezo for treating a variety of chronic inflammatory diseases in adults, including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

Cyltezo is a biosimilar of AbbVie’s Humira, a monoclonal antibody that generates annual sales of around $15 billion. Biosimilar versions are expected to be significantly cheaper than their expensive biologic counterparts, potentially saving substantial sums for healthcare providers.

Ivan Blanarik, senior vice president and head of therapeutic area biosimilars at Boehringer Ingelheim, said the approval marks a significant step forward for offering effective and more affordable treatment options for patients with chronic inflammatory diseases. “We believe biosimilars will be a key contributor to the future sustainability of healthcare systems around the world.”

According to the German producer, the drug’s approval, which also covers certain pediatric inflammatory diseases, was based on a comprehensive data package supporting the biosimilarity of Cyltezo to Humira and comprising analytical, pharmacological, non-clinical and clinical data.

However, Boehringer Ingelheim said it does not intend to make Cyltezo commercially available in Europe until the respective supplementary protection certificate (SPC) for Humira expires in October 2018. An SPC extends the duration of certain rights associated with a patent.

Cyltezo was also approved in the US in late August, just a few weeks after AbbVie filed suit against Boehringer in a Delaware federal court. AbbVie is reported to hold more than 100 patents on Humira with the likelihood that the German drugmaker could infringe 74 of them with its biosimilar version.