Int’l journal publishes therapeutic equivalence of Celltrion’s Omlyclo

Celltrion CI

South Korean biosimilar developer Celltrion Inc. announced on Wednesday that the results from its global Phase 3 clinical trial confirming the therapeutic equivalence of its biosimilar CT-P39 (brand name Omlyclo) at week 40 have been published in the international academic journal Clinical and Translational Allergy (CTA).

Omlyclo is a biosimilar of Xolair (omalizumab), an antibody biopharmaceutical developed by global pharmaceutical companies Genentech Inc. and Novartis International AG.

Xolair raised about 6 trillion won ($4.36 billion) in global sales as of last year.

The study included 619 patients with chronic spontaneous urticaria and assessed the efficacy and safety of the drug after a 24-week treatment period followed by a 16-week follow-up.

Five groups were compared in the study: 300 milligram (mg) CT-P39 monotherapy; crossover from 300 mg Xolair to 300 mg CT-P39; 300 mg Xolair monotherapy; up-dosing from 150 mg to 300 mg CT-P39; and up-dosing from 150 mg to 300 mg Xolair.

Celltrion said that similar trends were observed across all treatment groups, supporting the therapeutic equivalence of the biosimilar.

Omlyclo has been approved as the first Xolair biosimilar in major global markets including Korea, the United States, the United Kingdom, and Canada.

In the U.S., it has been designated as an interchangeable biosimilar, meaning it can be substituted for the original product at the pharmacy level without a prescriber’s intervention.

“We aim to secure a leading position in the global omalizumab market,” the company said. “We will accelerate efforts to penetrate the market.”