2025. 2. 18. 17:23ㆍKorean Economy
South Korean biopharmaceutical company Celltrion announced on the 18th that it has received approval from the European Medicines Agency (EMA) to proceed with a global Phase 3 clinical trial for CT-P55, a biosimilar of Cosentyx (secukinumab).
With this approval, Celltrion will initiate a global Phase 3 trial involving 375 patients with plaque psoriasis to assess the efficacy, safety, and equivalence of CT-P55 compared to the original drug, Cosentyx.
Cosentyx is an interleukin-17A (IL-17A) inhibitor used to treat autoimmune diseases, including ankylosing spondylitis, psoriatic arthritis, and moderate-to-severe plaque psoriasis. The global sales of Cosentyx reached approximately $6.14 billion (KRW 8.6 trillion) in 2023. The drug’s substance patent is set to expire in January 2029 in the U.S. and July 2030 in Europe.
By developing CT-P55, Celltrion aims to strengthen its presence in the autoimmune treatment market, where it already holds a competitive advantage. The company is also preparing to launch Yuflyma, a biosimilar for Humira (adalimumab), in major markets after securing regulatory approvals.
A Celltrion representative stated, "Now that we have entered the clinical trial phase, we will make every effort to further strengthen our autoimmune treatment pipeline."