2024-07-09 16:07:45
Targeting the global 5 trillion omalizumab market
Obtained product approval in the UK following Europe and Korea
Zolair, treatment for allergic diseases such as asthma and hives
Expanding portfolio following autoimmune diseases and anticancer drugs
Celltrion announced on the 9th that its XOLAIR (ingredient name: omalizumab) biosimilar ‘OMLYCLO (CT-P39)’, which treats allergic asthma and chronic idiopathic urticaria, has received approval for marketing from the Medicines and Healthcare products Regulatory Agency (MHRA), the UK health authority.
Indications include allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic idiopathic urticaria. This approval was obtained based on the results of a global phase 3 clinical trial conducted on 619 patients with chronic idiopathic urticaria in six European countries. It has proven efficacy and equivalence compared to the original drug, and has also confirmed similarity in terms of safety.
Celltrion’s Omriclor was approved as the first Xolair biosimilar in Korea last month, following Europe in May. It is evaluated that it has secured the status of ‘first mover’ in the omalizumab market by obtaining approval in the UK, one of the major European markets.
The original drug, Xolair, is a blockbuster product with global sales of approximately 5 trillion won as of last year. Of this, the UK market is known to be worth approximately 87.1 billion won.
Celltrion has expanded its portfolio to include allergy treatment drugs in addition to existing autoimmune disease treatment drugs and anticancer drugs.
A Celltrion official said, “Omriclor is the first Xolair biosimilar to be approved in the UK, and we plan to quickly conquer the market based on the first-mover advantage,” adding, “We will do our best to ensure that many patients suffering from allergic diseases can enjoy new treatment options.”
Meanwhile, Celltrion recently obtained approval for follow-up pipeline products such as Omriclor, Stekima, and Idenzelt. It is evaluated that follow-up product development and approval are proceeding smoothly in line with the previous announcement. Products that were released first are also smoothly increasing their market share, raising expectations for strengthening global market influence and expanding sales in the future.
Kim Min-beom, Donga.com reporter [email protected]
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2024-07-09 16:07:45