Celltrion Reveals Positive Clinical Trial Data for Biosimilar Adalimumab

Celltrion Healthcare, a global biopharmaceutical company, has revealed positive one-year results from a Phase III trial comparing the efficacy and safety of biosimilar adalimumab, Yuflyma (CT-P17), with the reference adalimumab in patients with rheumatoid arthritis (RA).

In a June 2, 2021 press release, the company announced that both primary and secondary endpoints of the trial had been met, which demonstrates that Yuflyma has comparative efficacy, pharmacokinetics (PK), safety, and immunogenicity to the reference adalimumab in the treatment of patients with moderate-to-severe active RA up to one year. The randomized, double-blind, Phase III trial included 648 patients and an abstract has been published in an official supplement to the Annals of Rheumatic Diseases.

Professor Jonathan Kay of the University of Massachusetts Medical School and principal investigator of the trial said, in the press release, “CT-P17 is administered at 100 mg/mL, reflecting the high-concentration formulation of reference adalimumab, and is also citrate-free, which could lessen discomfort during injection. Demonstration of equivalent efficacy and comparable safety of CT-P17 to [European Union] EU-sourced adalimumab in this study supports the ongoing clinical evaluation of CT-P17 as an adalimumab biosimilar.”

Furthermore, Celltrion has announced that the European Commission (EC) has granted marketing authorization for Remsima SC (infliximab), which is to be used without intravenous infusion in both new and existing RA patients.

“Celltrion now has biosimilars of both infliximab and adalimumab with value-added features, and thus CT-P17 could be used sequentially with Remsima SC to bring clinical benefit for chronic diseases which require long-term treatment,” added HoUng Kim, PhD, head of Medical and Marketing Division at Celltrion Healthcare, in the press release. “Having both Remsima SC and Yuflyma in our product pipeline furthers our efforts to deliver value-added medicines to both payers and patients.”

Source: Celltrion