Celltrion seeks European approval for Actemra biosimilar

Celltrion

13 February 2024 - Celltrion said it has completed its application for marketing authorisation to the EMA for CT-P47, a biosimilar referencing Actemra.

Celltrion decided to apply for approval based on the results from a global phase 3 clinical trial that demonstrated the biosimilar's equivalence and similarity to the original Actemra in treating rheumatoid arthritis, involving 471 patients.

Read Korea Biomedical Review article

Michael Wonder

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Michael Wonder

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Medicine , Europe , Biosimilar , Dossier