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 time from about 90 minutes with the IV version to approximately five minutes
- Celltrion has demonstrated its capabilities in SC commercialization with Remsima SC (U.S. brand: Zymfentra) and now plans to expand into CMO services, leveraging its SC formulation expertise to support external partners
Ref: Celltrion | Image: Celltrion | Press Release
Related News: Celltrion’s Steqeyma (Biosimilar, Stelara) Receives the CHMP Positive Opinion for Multiple Immune-Mediated Diseases
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