Singapore, Aug. 31 -- Taiwan-based Formosa Pharmaceuticals has submitted a Clinical Trial Application to European regulators for a pivotal study of TSY-110, its biosimilar candidate referencing the HER2-targeting antibody-drug conjugate ado-trastuzumab emtansine.

TSY-110 is being co-developed by Formosa Pharmaceuticals and EirGenix as a biosimilar to Roche's Kadcyla.

The reference therapy is used in HER2-positive metastatic and early-stage breast cancer.

The planned pivotal study has been designed following regulatory guidance from authorities in both the United States and Europe.

It will compare TSY-110 with the reference product across safety, tolerability, pharmacokinetics and immunogenicity.

Formosa Pharmaceuticals is seeking to ...