The US FDA Grants Approval to Celltrion's Steqeyma (Biosimilar, Stelara)
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: Pr NewsWire | Image: Celltrion
Related News:- Celltrion’s Omlyclo (CT-P39) Secures the Health Canada’s Approval (Biosimilar, Xolair)
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
