Formosa Pharmaceuticals, Inc. (TWSE: 6838), a Taiwan-based biopharmaceutical company, announced on Friday that it has submitted a Clinical Trial Application (CTA) to European regulatory authorities to conduct a pivotal clinical trial of TSY-110.

The product is a biosimilar candidate referencing Roche's antibody-drug conjugate Kadcyla (ado-trastuzumab emtansine), indicated for HER2-positive metastatic and early-stage breast cancer.

The upcoming trial is designed subsequent to regulatory guidance from both US and EU authorities, and will assess the safety, tolerability, pharmacokinetics, and immunogenicity profile of TSY-110 compared with the reference product.