The European Commission recently approved Cyltezo, a biosimilar to Humira (adalimumab), for the treatment of chronic inflammatory diseases in adults and children including inflammatory bowel diseases (IBDs) such as Crohn’s disease and ulcerative colitis (UC).
Cyltezo developer Boehringer Ingelheim noted that the announcement follows the therapy’s clearance by the U.S. Food and Drug Administration (FDA) in August 2017 and a recent positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in September 2017.
The regulatory approvals are based on robust data that showed the similarity between Cyltezo and Humira. The data come largely from a pivotal Phase 3 study called VOLTAIRE-RA (NCT02137226), which demonstrated the clinical bioequivalence of Cyltezo to Humira in people with moderately to severely active rheumatoid arthritis (RA). Additionally, the study found no meaningful differences between Cyltezo and Humira in terms of safety and immunogenicity, or immune system response.
“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, Boehringer Ingelheim’s senior vice president and head of therapeutic area biosimilars, said in a press release. “We believe biosimilars will be a key contributor to the future sustainability of healthcare systems around the world.”
Based on these clinical trial data, Cyltezo was approved in the European Union for RA, and also for moderate to severe Crohn’s disease and moderate to severe UC, among others.
Cyltezo was also granted marketing authorization for the treatment of pediatric inflammatory diseases of the bowel, including Crohn’s disease in children 6 and older.
Boehringer Ingelheim will now wait until October 2018, when a market exclusivity agreement for Humira in the European Union expires. Cyltezo also is not yet available in the United States, as the company is currently engaged in patent negotiations with Humira owner AbbVie.
Humira is indicated for the treatment of inflammatory diseases including Crohn’s, UC, pediatric Crohn’s disease, and others. The FDA approved a biologics license application for Humira in 2002.
Cyltezo is the second Humira biosimilar to be approved by the FDA and the EU. Amgen’s Amjevita (adalimumab-atto) was the first. The FDA approved Amjevita in September 2016, and the EU approved it in March 2017.
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