Shots:
- Celltrion has receive the US FDA’s approval for Steqeyma, biosimilar version of J&J’s Stelara (ustekinumab), to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease, & ulcerative colitis
- The approval was supported by P-III study in mod. to sev. plaque psoriasis with 1EP as change in the PASI for skin symptoms, showing therapeutic equivalence b/w Steqeyma vs reference
- Ustekinumab is a mAb that inhibits IL-12 and IL-23, responsible for inflammatory & immune responses. Celltrion will commercialize Steqeyma in Feb 2025 as per a settlement and license agreement with J&J
Ref: Celltrion | Image: Celltrion | Press Release
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