Celltrion launches SteQeyma (Biosimilar, Stelara) in the US
Shots:
- Celltrion has launched SteQeyma (ustekinumab-stba) injection, a biosimilar to Stelara, for all indications of the reference products following the US FDA’s approval in Dec 2024
- Approval was supported by various clinical evidence incl. P-III trial of SteQeyma vs Stelara for mod. to sev. plaque PsO, with 1EP as rate of change in the PASI for skin symptoms, showing similar safety & efficacy b/w both the drugs
- SteQeyma, a human IL-12 & IL-23 antagonist, is available as SC injection (45mg/0.5mL or 90mg/1mL in a single-dose, prefilled syringes) & IV infusion (130mg/26mL solution in a single-dose vial) at an 85% discount to Stelara’s WAC price
Ref: Pr NewsWire | Image: Celltrion
Related News:- The US FDA Grants Approval to Celltrion’s Steqeyma (Biosimilar, Stelara)
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