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Celltrion

Celltrion Plans to File for Approval of Herzuma SC (Biosimilar, Herceptin) in Europe and Korea  

Shots:  Celltrion has completed the trial for Herzuma SC (CT-P6 SC), a biosimilar version of Herceptin (trastuzumab), and plans to file for marketing approval in the EU and Korea within three months  The trial, which demonstrated PK equivalence to the reference SC formulation, along with comparable safety and immunogenicity, also met its 1EP. Herzuma SC is also expected to enhance patient convenience by reducing administration…

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