Celltrion Aims for World's First Approval of 'Xolair Biosimilar'

'Asthma and Urticaria Treatment with Global Sales of 5 Trillion Won
EMA Approval Application Based on Interim Results of Phase 3 Clinical Trial'

Celltrion has taken the lead in the market by applying for European marketing authorization for the biosimilar of the allergy asthma and chronic urticaria treatment 'Xolair' (active ingredient omalizumab).

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

On the 24th (local time), Celltrion announced on the 25th that it had applied for European marketing authorization for CT-P39, developed as a biosimilar of Xolair. In terms of indications, the application covers the full label of Xolair’s existing indications, including allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria.

Xolair is an antibody biologic developed by Genentech and Novartis. It is a blockbuster drug that achieved global sales of 5 trillion KRW last year. Among its substance and formulation patents, the intravenous injection (IV) patent has expired, while the subcutaneous injection (SC) patent is set to expire in March next year in Europe and in November 2015 in the United States. CT-P39 is being clinically developed as an SC formulation, which offers greater convenience and drug stability compared to IV.

This application was made based on the interim results of the Phase 3 clinical trial disclosed earlier on the 10th. Celltrion demonstrated efficacy and equivalence compared to Xolair and confirmed similarity in safety in the global Phase 3 clinical trial interim results involving 619 patients with chronic spontaneous urticaria conducted in six countries including Poland and Bulgaria.

The clinical trial was planned for a total of 40 weeks, but Celltrion applied for approval to the European Medicines Agency (EMA) based on the interim results analyzed up to 24 weeks. The company explained, "If good results are confirmed in the interim data, it is possible to apply for approval based on the interim results through consultation with regulatory authorities." Regarding the primary endpoint, the change from baseline to week 12 in the weekly itch severity score was evaluated in the original 300 mg and CT-P39 300 mg administration groups, and the difference in mean change and the 95% confidence interval of the difference were 0.77, which fell within the pre-defined equivalence margin, statistically proving equivalence. Similar results were confirmed in secondary endpoints including efficacy, pharmacokinetics, safety, and immunogenicity assessments compared to the original drug.

Novartis' allergy asthma and chronic urticaria treatment 'Xolair'

With this application, Celltrion is expected to be the first to enter the Xolair biosimilar market. Currently, biosimilars of Xolair are being developed by Israel’s Teva and China’s CSPC Pharmaceutical Group, but no other company besides Celltrion has yet released Phase 3 clinical trial results. Celltrion plans to sequentially apply for approval in Korea and other major countries overseas.

A Celltrion official stated, “By formalizing the approval process for CT-P39’s global market entry, we have expanded our portfolio to include treatments for allergic diseases in addition to autoimmune diseases and anticancer drugs, where we have demonstrated strengths. We will do our best to ensure that the remaining approval procedures proceed smoothly so that high-quality biopharmaceuticals can be supplied seamlessly to the global market.”

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