European Commission Approves Cyltezo, Humira’s Biosimilar, for Chronic Inflammatory Diseases

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by Ana de Barros PhD |

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Boehringer Ingelheim announced that the European Commission has granted marketing authorization for Cyltezo, a biosimilar to Humira (adalimumab), for the treatment of ankylosing spondylitis (AS) and other chronic inflammatory diseases in adults and children.

The decision follows Cyltezo’s approval by the U.S. Food and Drug Administration (FDA) in August 2017 and a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in September 2017, based on data showing the similarity between Cyltezo and Humira.

Data from the pivotal Phase 3 study VOLTAIRE-RA (NCT02137226) demonstrated the clinical bioequivalence of Cyltezo (BI 695501) to Humira in people with moderate to severely active rheumatoid arthritis. The study also showed no clinically meaningful differences between the therapies regarding safety and immunogenicity.

“Cyltezo is the first biosimilar from Boehringer Ingelheim approved in Europe, and marks a significant step forward for us in offering effective, and more affordable treatment options for patients with chronic inflammatory diseases,” Ivan Blanarik, senior vice president and head of therapeutic area biosimilars at Boehringer Ingelheim, said in a press release.

“We believe biosimilars will be a key contributor to the future sustainability of healthcare systems around the world,” Blanarik added.

In addition to severe active AS, Cyltezo has been approved for several chronic inflammatory diseases including severe axial spondyloarthritis without radiographic evidence of AS, moderate-to-severe rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, and chronic plaque psoriasis, among others.

Cyltezo was also granted marketing authorization for the treatment of certain pediatric inflammatory diseases, including Crohn’s disease (for children 6 and older), chronic plaque psoriasis (for children 4 and older), enthesitis-related arthritis (for children 6 and older), and polyarticular juvenile idiopathic arthritis (for children 2 and older).

Cyltezo is not yet commercially available in Europe or the United States. Boehringer Ingelheim will wait until October 2018 for the expiration of the respective market exclusivity agreement for Humira in the European Union. In the U.S., the company is currently engaged in patent litigation with AbbVie, the company that owns Humira.