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Celltrion Presents Encouraging Findings from its Phase III Trial of CT-P47, a Biosimilar to RoActemra® (tocilizumab)

Jun 13, 2024

On 13 June 2024, at the Annual European Congress of Rheumatology, Celltrion announced positive Phase III results for CT-P47, a biosimilar referencing RoActemra®, in patients suffering from moderate-to-severe rheumatoid arthritis. The Phase III comparative clinical trial data showed that CT-P47 exhibits comparable efficacy and a similar safety and immunogenicity profile to the reference tocilizumab product. 

This news follows South Korean approval of Celltrion’s Steqeyma (CT-P43), a biosimilar to J&J’s Stelara® (ustekinumab). Celltrion is also seeking approval for Steqeyma in Europe, the United States, and Australia.  The company submitted applications with the EMA in May 2023, the FDA in June 2023, and the TGA in April 2023.