Tony Hagen is senior managing editor for The Center for Biosimilars®.
The recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP) bodes well for a final marketing authorization for the adalimumab biosimilar candidate.
Celltrion’s high-concentration, citrate-free adalimumab biosimilar candidate (CT-P17, Yuflyma) has been recommended for marketing authorization by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. The European Commission, which authorizes medicinal products for the European Union, will make the final decision, but is strongly influenced by CHMP.
CT-P17 is intended for the treatment of 12 chronic inflammatory diseases, including rheumatoid arthritis (RA), psoriatic arthritis, and Crohn disease. CHMP recommended approval for all 12. Celltrion said the positive opinion is based on equivalency studies demonstrating efficacy, pharmacokinetics (PK), and overall safety compared with the reference product, Humira.
CT-P17 would be the first high-concentration (100 mg/mL), citrate-free adalimumab biosimilar. “Having a high-concentration and citrate-free formulation would provide patients less pain during administration leading to improved quality of life,” said Edward Keystone, MD, FRCPC, senior consultant rheumatologist at Mount Sinai Hospital in Toronto, Canada, in a statement.
There are at least 9 marketing-authorized versions of adalimumab in the European Union. There are 6 FDA-approved adalimumab biosimilars in the United States—but none of these is expected to reach market until 2023. A European Commission decision on the Celltrion product is expected in the first quarter of 2021.
The other proposed indications for CT-P17 are juvenile idiopathic arthritis, axial spondyloarthritis, psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa, pediatric Crohn disease, ulcerative colitis, uveitis, and pediatric uveitis.
Results of a phase 3 study in patients with RA was presented at the American College of Rheumatology Convergence 2020. In the randomized study, CT-P17 met the primary objective of efficacy and safety comparable to the standard for the reference product.
Efficacy, PK, and safety equivalence to the reference product also were demonstrated in a separate, randomized, double-blind, single-dose phase 1 study in healthy individuals up to 10 weeks. “The CHMP positive opinion is very encouraging as CT-P17 has demonstrated promising study results in efficacy, PK and safety profile compared to reference adalimumab,” Keystone said.