Shots:
- The US FDA has approved Steqeyma (45mg/0.5mL, SC, single-dose vial), a biosimilar version of Stelara (ustekinumab) for the treatment of pts (6-17yrs.; ≤60kg) with plaque PsO or PsA
- Approval was supported by extensive clinical data, 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 is available as SC injection (45mg/0.5mL or 90mg/1mL) & IV infusion (130mg/26mL), with approved interchangeability for all Stelara indications following exclusivity expiration on April 30, 2025
Ref: Prnewswire| Image: Celltrion| Press Release
Related News:- Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation
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