Shots:
- Celltrion has applied to Health Canada for marketing authorization for CT-P55, a biosimilar of Cosentyx (secukinumab), for all indications held by the reference product, including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis
- The application was based on a clinical study in 172 healthy subjects, in which CT-P55 demonstrated pharmacokinetic equivalence to the reference product and comparable safety and immunogenicity
- CT-P55, an IL-17A inhibitor, is expected to strengthen Celltrion’s autoimmune portfolio, with plans to pursue approvals in the US, Europe, and South Korea to expedite commercialization
Ref: Celltrion | Image: Celltrion | Press Release
Related News: Celltrion Plans to File for Approval of Herzuma SC (Biosimilar, Herceptin) in Europe and Korea
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