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Celltrion’s Steqeyma (Biosimilar, Stelara) Receives the Health Canada’s Approval to Treat Various Chronic Inflammatory Conditions 

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  • Health Canada has approved Steqeyma injection & Steqeyma I.V. (injection, solution for IV infusion), biosimilar versions of Stelara (ustekinumab) to treat adults with moderate to severe active Crohn’s disease & plaque PsO as well as active psoriatic arthritis 
  • Approval was supported by the P-III trial of Steqeyma vs Stelara, with the 1EP as rate of change in the psoriasis area & severity index for skin symptoms after 52wks. The efficacy was similar in patients who switched to Steqeyma at wk.16 
  • Steqeyma, an IL-12 & -23 antagonist, is accessible in both IV [130mg/26 mL (5mg/mL) solution in a single-dose vial] & SC (45mg/0.5mL or 90mg/1mL solution in a single-dose, prefilled syringe) formulations 

Ref: Businesswire | Image: Celltrion | Press Release

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