Celltrion files MAA with EMA for biosimilar to Janssen’s Stelara® (ustekinumab)

May 26, 2023

Korea Biomed has reported that Celltrion filed a marketing authorisatn application with the EMA for CT-P43, its biosimilar to Janssen’s Stelara® (ustekinemab).  Based on its phase III clinical trial in plaque psoriasis patients, which demonstrated similar efficacy, pharmacokinetic, and safety results between CT-P43 and Stelara®, Celltrion’s MAA sought approval for all Stelara® indications.  Celltrion confirmed it intends to seek approval in other key countries.

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