Formosa Pharmaceuticals Begins European Trials for Kadcyla Biosimilar
Formosa Pharmaceuticals has filed a Clinical Trial Application with European regulators for TSY-110, an antibody-drug conjugate designed as a biosimilar to Roche’s Kadcyla. This move aims to challenge the market dominance of the HER2-positive breast cancer therapy by offering a cost-effective alternative to the established standard of care.
The upcoming pivotal trial will assess the safety, pharmacokinetics, and immunogenicity of TSY-110, also known as EG12043, in comparison to the reference product. Co-developed with EirGenix, the drug utilizes a trastuzumab monoclonal antibody linked to a mertansine cytotoxic payload to target HER2-overexpressing cells. Preclinical data indicates high biosimilarity and consistent drug-antibody ratios, mirroring the performance of the original therapy.
Erick Co, CEO of Formosa Pharmaceuticals, emphasized that the filing addresses the persistent issue of high treatment costs for oncology patients. Kadcyla, which received FDA approval in 2013, remains a primary tool in breast cancer treatment and generated approximately $2.5 billion in global sales in 2025. With HER2-positive breast cancer affecting hundreds of thousands of patients annually, the introduction of a biosimilar could significantly alter the current therapeutic landscape.
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