The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the use of Boehringer Ingelheim’s Cyltezo, an adalimumab biosimilar, for the treatment of a range of chronic inflammatory diseases in adults and children, including juvenile arthritis.
A biosimilar is a biological product that is approved for medical treatment because it is very similar to another previously approved product (known as the biological reference product). Its sponsor must prove it has no clinically meaningful difference to the reference product regarding safety and clinical effectiveness. It also must work in the same way as the reference product, and have the same route of administration, dosage form, and strength.
There are fewer costs associated with developing a biosimilar, so it is considered a low-cost alternative to the reference product.
Cyltezo is a biosimilar to the reference product Humira (adalimumab). It acts by binding to and blocking the activity of tumor necrosis factor (TNF), a protein of the immune system which promotes inflammation.
The recommendation by the CHMP is based on non-clinical and clinical data, including a Phase 3 trial (NCT02137226), demonstrating the efficacy and clinical equivalence of Cyltezo to Humira in the treatment of moderate to severely active rheumatoid arthritis.
Cyltezo is intended for the treatment of a number of pediatric inflammatory diseases, including moderate to severe Crohn’s disease, severe chronic plaque psoriasis, enthesitis-related arthritis, and plyarticular juvenile idiopathic arthritis.
In addition to these conditions, the CHMP also recommends the approval of Cyltezo for treating chronic inflammatory diseases in adults, including moderate to severely active rheumatoid arthritis and severe active ankylosing spondylitis.
“Chronic inflammatory diseases can be incredibly debilitating and we are delighted that Cyltezo has the potential to improve the lives of many of these patients. Boehringer Ingelheim is committed to supporting the long-term potential of biosimilars, which we believe will be a key contributor to the future sustainability of healthcare systems around the world,” Ivan Blanarik, senior vice president and head of therapeutic area biosimilars at Boehringer Ingelheim, said in a press release.
The U.S. Food and Drug Administration (FDA) approved Cyltezo’s use as a biosimilar in August 2017. The European Commission is expected to make a decision on the marketing approval of Cyltezo later this year.