Celltrion announced on the 23rd that it has obtained product approval for its autoimmune disease treatment biosimilar 'Abtozmaju' (development name CT-P47) from the Ministry of Food and Drug Safety. With this approval, the company has successfully achieved its business vision of establishing an '11-product portfolio by 2025' earlier than planned.
With this approval, Actemra has obtained approval for all indications, including rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), and polyarticular juvenile idiopathic arthritis (pJIA) in South Korea. Previously, the company applied for domestic product approval for Abtozmaju based on the results of global Phase 3 clinical trials.
Abtozmaju is the first approved biosimilar of Actemra (ingredient name tocilizumab) in South Korea. Actemra, developed by Swiss company Roche, is a treatment that inhibits the protein interleukin (IL)-6 involved in causing inflammation in the body, with global sales of approximately 2.63 billion Swiss francs (about 4 trillion won) recorded last year.
Celltrion has recently obtained a recommendation for European product approval from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) for Abtozma and has completed product approval applications to the U.S. Food and Drug Administration (FDA), moving forward with the approval processes in major global countries. The company noted that it aims to secure a 'first mover' status with the first domestic approval of an Actemra biosimilar while intensifying its efforts to target the global tocilizumab market.
A Celltrion official said, 'By obtaining the product approval for the interleukin inhibitor Abtozmaju, we have significantly enhanced our competitiveness in the autoimmune disease treatment market,' and added, 'We will do our utmost to ensure the approval and commercialization processes are carried out smoothly in major countries around the world, so that high-quality biopharmaceuticals can be supplied to patients both domestically and internationally at an early date.'