Approved in Europe following South Korea and Canada,
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Celltrion headquarters in Songdo, Incheon.,
, ‘ Celltrion announced on the 26th that its biosimilar ‘Stekima’ of the autoimmune disease treatment drug Stelara (generic name Ustekinumab) has obtained marketing authorization from the European Commission (EC).’
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, ‘Stekima has been granted market approval for major indications of the original drug, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, etc. This comes just about two months after receiving a ‘positive opinion’ from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) at the end of June, following approvals in South Korea and Canada in June and July.’
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, ‘According to IQVIA, a pharmaceutical market research firm, the global market size for Ustekinumab was approximately $20.4 billion (about 26.52 trillion won) last year, with the European market estimated at around $3.15 billion (about 4.365 trillion won), accounting for about 15% of the global market.’
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, ‘Celltrion plans to accelerate its market expansion in the global autoimmune disease treatment field, including Ustekinumab. A company official stated, “With Stekima joining the portfolio of tumor necrosis factor-alpha (TNF-α) inhibitors such as Remsima, Remsima SC (branded as Inflectra in the U.S.), and Yuflyma, as well as the interleukin (IL) inhibitor Stekima, the range of patients for treatment is expected to expand further.”‘
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, ‘Celltrion aims to leverage a bundling strategy of selling multiple products together when expanding its approved and commercialized products rapidly to enhance its market competitiveness and negotiation power. The company stated, “We will do our best to supply the necessary treatments to patients by quickly launching Stekima in major global markets,” and added, “We will also accelerate the development of our pipeline to expand our market dominance.”‘
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, ‘As part of Celltrion’s pipeline for autoimmune diseases, there are CT-P47 (Actemra biosimilar), CT-P53 (Ocrevus biosimilar), CT-P55 (Cosentyx biosimilar), and more. Celltrion plans to secure a portfolio of 11 biosimilars by 2025, not only in the field of autoimmune diseases but also in areas like cancer treatment, bone diseases, and ophthalmic diseases, either through obtaining new product approvals or entering pipeline clinical trials.’
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