Shots:
- Following the CHMP’s positive opinion in Jun 2024, the EC has approved SteQeyma, a biosimilar version of Stelara (ustekinumab), for treating various chronic inflammatory diseases. Approved as biologic for gastroenterology, dermatology & rheumatology indications
- Approval was supported by the P-III trial of SteQeyma vs Stelara for moderate to severe plaque PsO, with 1EP as rate of change in the PASI for skin symptoms, showing similar safety & efficacy b/w both the drugs
- SteQeyma (CT-P43), a human IL-12 & IL-23 antagonist, is available as SC injections (45mg/0.5mL or 90mg/1mL in a single-dose, prefilled syringes) & IV infusion (130mg/26mL solution in a single-dose vial)
Ref: Celltrion| Image: Celltrion | Press Release
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