Celltrion's Stelara biosimilar recommended for EU approval


Celltrion announced on Monday that its ustekinumab biosimilar, CT-P43, has received a recommendation for approval from the European Medicines Agency's Committee for Medicinal Products for Human Use. This recommendation is a significant step towards the final approval of the biosimilar product in Europe. Stelara, the reference drug for CT-P43, is a top-selling medication for various conditions including psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, with the global market for ustekinumab estimated at around $20 billion last year. Celltrion expressed optimism about the regulatory approval of its biosimilar product in Europe and is preparing for its domestic launch in South Korea after receiving approval from the Ministry of Food and Drug Safety. Celltrion's efforts to introduce new biosimilar products in overseas markets have been yielding positive outcomes, with the recent approval of Omlyclo (CT-P39) in Europe and the submission of a marketing authorization application for CT-P42. The company is also actively pursuing clinical studies for new biosimilar candidates, such as CT-P55, which is a biosimilar referencing Novartis' psoriasis treatment Cosentyx. With plans to expand its biosimilar portfolio to 11 by 2025, Celltrion aims to establish itself as a global biosimilar producer.


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