On 31 July 2024, Celltrion reported that Health Canada has approved its new drug licence application for Steqeyma (CT-P43), biosimilar to Janssen’s Stelara® (ustekinumab), for plaque psoriasis, psoriatic arthritis, and Crohn’s disease.
The Health Canada approval follows EMA’s recommendation for European marketing authorisation for Steqeyma and Celltrion’s earlier approval for Steqeyma in Korea on 12 June 2024. Celltrion is also seeking approval for Steqeyma in the United States and Australia, submitting applications with FDA in June 2023, and TGA in April 2023.