The European Commission has granted marketing authorization for Cyltezo, a biosimilar to Humira (adalimumab) developed by Boehringer Ingelheim, for adults and children with several chronic inflammatory diseases including juvenile arthritis.
The company expects to begin marketing Cyltezo in the EU by October 2018, after a supplementary protection certificate that covers adalimumab expires.
“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.
The decision follows a recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in September 2017. The U.S. Food and Drug Administration (FDA) also approved Cyltezo, although Boehringer Ingelheim is currently involved in patent litigation in the U.S. with AbbVie, Humira’s manufacturer.
The European Commission’s decision on Cyltezo’s marketing application was supported by extensive pharmacological, clinical, and non-clinical data demonstrating the similarities between Cyltezo and its reference therapy, Humira.
This included data from the pivotal Phase 3 VOLTAIRE-RA trial (NCT02137226), which showed the clinical equivalence of Cyltezo compared to Humira in patients with moderate to severely active rheumatoid arthritis.
The EU has approved Cyltezo’s use for the following pediatric conditions:
- polyarticular juvenile idiopathic arthritis (children 2 and older),
- moderate to severe Crohn’s disease (children 6 and older),
- severe chronic plaque psoriasis (children 4 and older),
- enthesitis-related arthritis (children 6 and older).
For adults, Cyltezo is approved for:
- rheumatoid arthritis,
- psoriatic arthritis,
- inflammatory bowel disease,
- ankylosing spondylitis,
- axial spondyloarthritis,
- plaque psoriasis,
- hidradenitis suppurativa.
“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,” Blanarik said. “We believe biosimilars will be a key contributor to the future sustainability of healthcare systems around the world.”