Celltrion said it has completed a marketing authorization application for CT-P39, a biosimilar referencing Xolair (ingredient: omalizumab), to the European Medicines Agency (EMA).
Xolair, the original drug, is an antibody biologic developed by Genentech and Novartis for the treatment of allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic idiopathic urticaria.
The treatment is a blockbuster product with global sales of approximately $5 trillion in 2022. The substance patent has already expired, and the formulation patent is scheduled to expire in March 2024 in Europe and November 2025 in the U.S.
The filing comes after Celltrion demonstrated efficacy and equivalence of CT-P39 compared to the original drug in the global phase 3 clinical trial in 619 patients with chronic spontaneous urticaria in Poland, Bulgaria, and six other countries.
Based on these clinical results, Celltrion has submitted a full-label application to the EMA for the full range of indications approved for the original drug, including allergic asthma, chronic rhinosinusitis, and chronic urticaria.
The company also stressed that it plans to apply for approval in Korea and major overseas countries sequentially within the year.
"As we move forward with the approval process for CT-P39 to enter the global market, we are expanding our portfolio to a variety of diseases, including allergic diseases, in addition to autoimmune diseases and anticancer drugs, where we have shown our strength," a Celltrion official said.
In consultation with regulatory authorities, the company will do its best to smoothly proceed with the remaining approval process so that high-quality biopharmaceuticals can be supplied to the global market, he added.
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