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Celltrion Submits EMA Marketing Authorization Application for Cosentyx Biosimilar CT-P55

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Celltrion (KRX:068270) has submitted a marketing authorization application to the European Medicines Agency and European Commission for CT-P55, a biosimilar to Cosentyx (secukinumab), according to a bourse filing on Friday.

The company seeks approval for adult plaque psoriasis, psoriatic arthritis, hidradenitis suppurativa, and axial spondyloarthritis, plus pediatric plaque psoriasis and juvenile idiopathic arthritis subtypes.

The application is based on a Phase 1 trial in 172 healthy subjects that demonstrated pharmacokinetic equivalence to Cosentyx, with similar safety profiles and low immunogenicity across both groups.

The company cautions that submitting an application does not guarantee final approval, and regulatory reviews may yield unexpected outcomes or lead to changes in commercialization plans.

This MAA follows prior EMA submissions and approvals for the drug's clinical trial applications between 2023 and 2026.

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