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ARTICLE · 05 SEPTEMBER 2024

Update On Recent International Biosimilar Approvals

Goodwin Procter LLP
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Approval of Celltrion's Ustekinumab Biosimilar in the EU: On August 26, 2024, Celltrion announced that the European Commission (EC) granted approval for STEQEYMA, formerly known as CT-P43...

United StatesMedia, Telecoms, IT, Entertainment
Yoko Bian
Yoko Bian

Approval of Celltrion's Ustekinumab Biosimilar in the EU: On August 26, 2024, Celltrion announced that the European Commission (EC) granted approval for STEQEYMA, formerly known as CT-P43, a biosimilar of STELARA (ustekinumab), for the treatment of several chronic inflammatory conditions. STEQEYMA is a human IL-12 and IL-23 antagonist indicated for multiple immune-mediated diseases. It is available in both subcutaneous and intravenous forms. The subcutaneous injection comes in two strengths: 45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled syringe. The intravenous infusion is provided as a 130mg/26 mL (5mg/mL) solution in a single-dose vial. This EC approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2024.

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