- Formosa Pharmaceuticals has submitted a Clinical Trial Application (CTA) to European regulatory authorities for a pivotal clinical trial of TSY-110, a biosimilar candidate referencing Roche’s Kadcyla (ado-trastuzumab emtansine).
- The trial will assess the safety, tolerability, pharmacokinetics and immunogenicity of TSY-110 against the reference product in HER2-positive breast cancer.
Formosa Pharmaceuticals has submitted a Clinical Trial Application to European regulatory authorities to conduct a pivotal clinical trial of TSY-110, a biosimilar candidate referencing Roche’s antibody-drug conjugate (ADC) Kadcyla (ado-trastuzumab emtansine). Kadcyla is indicated for HER2-positive metastatic and early-stage breast cancer.
The planned trial was designed in accordance with regulatory guidance from both US and European authorities. It will compare TSY-110 with the reference product, evaluating safety, tolerability, pharmacokinetics and immunogenicity. The filing advances Formosa Pharmaceuticals’ and EirGenix’s development programme for a biosimilar ADC intended for regulated global markets.
TSY-110 is being developed as an ADC biosimilar for HER2-positive breast cancer. Formosa said the programme is intended to support access to cost-effective biosimilar ADC treatments, where treatment costs can constrain patient access.
“Filing this CTA marks a significant achievement for Formosa Pharmaceuticals and underscores our strategic alliance with EirGenix. Advancing TSY-110 into clinical evaluation is a momentous step toward fulfilling our goal of delivering world-class, accessible ADC options to oncologists and patients.”
Erick Co, Ph.D., President and Chief Executive Officer of Formosa Pharmaceuticals
