CSPC Pharmaceutical Reports the NMPA Approval of Secukinumab Injection (Biosimilar, Cosentyx)
Shots:
- The Chinese NMPA has accepted the marketing application for its secukinumab injection, a biosimilar version of Cosentyx, submitted as a Class 3.3 therapeutic biologic
- The marketing authorization application is supported by a P-I PK similarity study in healthy volunteers and a P-III equivalence study in psoriasis pts, demonstrating that the product is highly similar to Cosentyx in efficacy, safety, PK, and immunogenicity. Detailed results will be presented at upcoming scientific conferences and published in peer-reviewed journals.
- Secukinumab is a fully human IgG1 mAb that selectively targets IL-17A, blocking its interaction with the IL-17A receptor
Ref: CSPC Pharmaceutical | Image: CSPC Pharmaceutical | Press Release
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