Celltrion said it confirmed the bioequivalence of CT-P39, a biosimilar referencing Xolair (ingredient: omalizumab), compared to the original drug through a global phase 3 clinical trial.

The company presented the results during the American College of Allergy, Asthma and Immunology (ACAAI) 2023, held in Anaheim, California from Thursday to Monday (local time).

Xolair, developed by Genentech and Novartis, is an antibody biopharmaceutical used for treating allergic asthma, chronic spontaneous urticaria, and chronic rhinosinusitis.

According to IQVIA, a drug market research company, Xolair achieved global market sales of $3.89 billion last year, with its compound patent already expired and its formulation patent set to expire in March 2024 in Europe and November 2025 in the U.S.

Celltrion is currently conducting a 40-week clinical trial starting with the first administration of either CT-P39 or Xolair on 619 patients with chronic spontaneous urticaria (CSU) across six countries, including Poland and Bulgaria.

CT-P39 and Xolair were administered to groups in dosages of 300mg and 150mg, and the change in the Weekly Itch Severity Score (ISS7) from baseline at week 12 was measured as the primary endpoint.

As a result, CT-P39 met the predefined equivalence criteria and showed similar results in secondary endpoints such as safety and immunogenicity compared to Xolair.

Celltrion completed the application for approval of CT-P39 in Europe and Korea in April and June and plans to apply for approval in major global markets sequentially.

The company aims to be the first to launch a Xolair biosimilar in major global markets by accelerating the approval process, highlighting the development speed advantage over competitors.

"We have presented Phase 3 clinical data on CT-P39 for patients with chronic spontaneous urticaria at ACAAI, proving its therapeutic equivalence to the original," a Celltrion official said. "Based on these clinical results, we will proceed with the global approval process and do our best to be the first company to supply high-quality Xolair biosimilar to major countries."