Shots:
- Formosa has submitted a CTA to European regulatory authorities for a pivotal trial of TSY-110 (ado-trastuzumab emtansine), a biosimilar Version of Roche’s Kadcyla for HER2-positive breast cancer
- The trial will evaluate TSY-110’s safety, tolerability, PK, and immunogenicity versus the reference product; preclinical data show high biosimilarity, consistent DAR, and comparable plasma kinetics
- TSY-110 (EG12043) is an ADC biosimilar co-developed by Formosa Pharmaceuticals and EirGenix, combining trastuzumab with mertansine to selectively target HER2-overexpressing cancer cells. The program aims to expand access to cost-effective biosimilar ADC treatments in global regulated markets
Ref: Formosa | Image: Formosa | Press Release
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