Celltrion Presents Clinical Results Poster for 'CT-P39', a Biosimilar of 'Xolair'

Celltrion announced on the 13th that it presented the global Phase 3 clinical trial results of 'CT-P39,' a biosimilar (biopharmaceutical generic) developed as a biosimilar to 'Xolair (active ingredient omalizumab),' a treatment for allergic asthma and chronic spontaneous urticaria, at the American College of Allergy, Asthma & Immunology (ACAAI 2023) on the 12th (local time).

Incheon Songdo Celltrion Plant 2 exterior view. / Incheon - Photo by Hyunmin Kim kimhyun81@

Celebrating its 81st year this year, ACAAI is a prestigious American allergy, asthma, and immunology society held over five days from the 9th to the 13th in California, USA. It is also conducted online simultaneously.

Celltrion is currently conducting a 40-week clinical trial after the first dose on 619 patients with Chronic Spontaneous Urticaria in six countries including Poland and Bulgaria. At this conference, the 12-week observation results for 409 patients randomized to receive either CT-P39 or Xolair at a 300 mg dose were disclosed in a poster presentation.

Celltrion conducted dosing clinical trials divided into CT-P39 and Xolair groups with doses of 300 mg and 150 mg respectively. In the 300 mg dosing group, the primary endpoint was the change in weekly itch score (ISS7) at week 12 compared to baseline. The results showed that CT-P39 met the predefined equivalence criteria, and similar results to the original drug were confirmed in secondary endpoints such as safety and immunogenicity assessments.

Celltrion has already applied for approval of CT-P39 in Europe and South Korea in April and June respectively. It plans to sequentially apply for approval in major global countries including the United States. In particular, leveraging its development speed advantage over competitors, it aims to be the first mover to launch in major global markets.

Xolair is an antibody biopharmaceutical developed by Genentech in the United States and Novartis in Switzerland, used to treat allergic asthma, chronic spontaneous urticaria, and chronic rhinosinusitis. According to the global pharmaceutical market research firm IQVIA, Xolair achieved blockbuster sales of $3.89 billion (approximately 5 trillion KRW) worldwide last year. The substance patent has already expired, and the formulation patent is set to expire in March next year in Europe and November 2025 in the United States.

A Celltrion official stated, “At ACAAI, where medical professionals worldwide in the fields of allergy and chronic urticaria gather, we disclosed Phase 3 clinical data of CT-P39 for patients with chronic spontaneous urticaria, proving therapeutic equivalence to the original drug. Based on these clinical results, we will proceed smoothly with global approval procedures and do our best to supply high-quality biopharmaceuticals to major countries first as a first mover.”

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