'Market Size 5 Trillion Won' Jolleore Similar... Will Celltrion Take the Lead as First Mover?

Celltrion is accelerating its efforts to capture the 5 trillion KRW market by releasing clinical trial results of the biosimilar for the allergy and urticaria treatment drug 'Xolair' (active ingredient omalizumab).

Celltrion Plant 2.
[Photo by Celltrion]

On the 10th, Celltrion announced the global Phase 3 clinical trial results of the Xolair biosimilar 'CT-P39' for allergic asthma and chronic urticaria, confirming its efficacy and equivalence compared to the original drug. Celltrion is conducting clinical trials over 40 weeks after the first dose on 619 patients with chronic spontaneous urticaria in six countries including Poland and Bulgaria. The current results cover up to 24 weeks of the trial.

In this clinical trial, Celltrion measured the change in weekly itch score from baseline at week 12 as the primary endpoint in both the CT-P39 300 mg group and the original drug 300 mg group. The results showed that CT-P39 met the predefined equivalence criteria. Secondary endpoints including efficacy, pharmacokinetics, safety, and immunogenicity assessments also demonstrated similar outcomes to the original drug. Celltrion plans to complete the remaining Phase 3 procedures and sequentially apply for approval in South Korea and major overseas countries within this year.

Xolair is an antibody biopharmaceutical developed by multinational pharmaceutical companies Genentech and Novartis, and it achieved global sales of 5 trillion KRW last year, making it a blockbuster product. This drug is mainly used to treat allergic asthma, chronic urticaria, and chronic rhinosinusitis.

Since the substance patent for Xolair has already expired, pharmaceutical companies worldwide including Celltrion are developing biosimilars. According to the global clinical trial information site ClinicalTrials, seven companies are currently conducting clinical trials for Xolair biosimilar development. Among them, three companies including Celltrion, Israel's Teva, and China's CSPC Pharma have entered Phase 3 trials. The remaining four companies are conducting Phase 1 trials. Among these, Celltrion was the first to start Phase 3 trials in December 2020. According to the site, Celltrion expects to complete Phase 3 trials by June this year.

Another distinguishing factor is that CT-P39 is being developed in a subcutaneous (SC) injection form. Celltrion explained that the Phase 3 trial was conducted using a prefilled syringe (PFS) SC formulation containing a single dose. The SC formulation offers advantages such as shorter administration time and higher convenience compared to intravenous (IV) formulations, as well as greater drug stability. The original drug Xolair is available in both IV and SC formulations. Among these, the IV formulation patent has already expired, and the SC formulation patent is nearing expiration in major countries including Europe and the United States.

Meanwhile, some companies are developing allergy treatments themselves beyond biosimilars. Yuhan Corporation is conducting a Phase 1 clinical trial in South Korea for 'YH35324,' an allergy treatment candidate. This trial is a comparative study with Xolair. The substance, licensed from GI Innovation by Yuhan Corporation, is a novel bispecific fusion protein drug that treats diseases such as urticaria caused by immunoglobulin E generated upon exposure to allergens. Yuhan Corporation plans to develop YH35324 as a future growth engine following the lung cancer drug 'Leclaza' through technology export.

This content was produced with the assistance of AI translation services.