2024-03-25 13:39:26
Securing all indications for original drugs
Potential to be the first Zolay biosimilar in the European market
Xolair’s global sales last year were about 5 trillion won.
Celltrion expects approval in May… Dominate the market as a ‘first mover’
Celltrion received approval from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) for full label approval for XOLAIR (XOLAIR (ingredient name: omalizumab) biosimilar ‘CT-P39’. It was announced on the 25th that it had submitted a recommendation for product approval.
Xolair, the original drug, is a blockbuster antibody biopharmaceutical used to treat allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic idiopathic urticaria. As of last year, global sales were estimated at approximately 5 trillion won. Recently, food allergy indications were additionally approved. The size of the related treatment market is expected to expand.
CHMP, which recommended product approval this time, is an organization that discusses approval or not based on scientific evaluation of drugs and presents opinions to EMA. In general, CHMP’s approval recommendations are known to play a decisive role in the final approval of the European Commission (EC). Therefore, CHMP’s approval recommendation opinion can be interpreted as actually indicating that there is a high possibility of approval by the European Medicines Agency.
Celltrion expects that the final product approval will be approved by the EC as early as May, based on the recommendations for product approval.
Upon approval, CT-P39 will become the first Xolair biosimilar approved in Europe. As a ‘First Mover’ product in the European market, it will be in an advantageous position to dominate the market. In line with this, Celltrion is aiming to quickly enter the market through rapid commercialization.
Xolair biosimilar CT-P39 is undergoing the approval process in the United States, one of the largest global markets, in addition to Europe. The application for product approval has already been completed with the U.S. Food and Drug Administration (FDA).
A Celltrion official said, “Once the European approval for CT-P39 is completed, we expect to be able to enter the market as a first mover and quickly expand our market share based on the first-mover effect.” He added, “This year, a number of products other than CT-P39 will be approved and launched globally. “As we plan to launch new items, we will accelerate our expansion of global market dominance and performance,” he said.
Meanwhile, Celltrion plans to focus on continuous product development and investment and expand its biosimilar product line to a total of 11 types by next year, in addition to the 6 products that have already been commercialized. The goal is to complete a total of 22 product lineups and achieve annual sales of 12 trillion won by 2030.
Kim Min-beom, Donga.com reporter mbkim@donga.com
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2024-03-25 13:39:26