Taiwanese Firm Submits Clinical Trial Application to EU for Breast Cancer Biosimilar

PharmaBlock, a Taiwanese pharmaceutical company, has reached a significant milestone by submitting a Clinical Trial Application (CTA) to European regulatory bodies for its biosimilar drug, TSY-110. This application initiates the process for pivotal clinical trials of the drug, which is developed for patients with HER2-positive metastatic and early-stage breast cancer.

TSY-110 is designed as a biosimilar to Kadcyla, an antibody-drug conjugate (ADC) developed by Roche. The clinical trial, structured according to guidelines from the US FDA and the European EMA, will evaluate TSY-110's safety, tolerability, pharmacokinetics, and immunogenicity in comparison to the reference drug, Kadcyla. This marks a crucial step in PharmaBlock's collaboration with Formosa Biologics.

"Submitting this CTA is a major achievement for PharmaBlock and highlights our strategic alliance with Formosa Biologics," stated PharmaBlock CEO, Eric Hu. He emphasized that ADCs have become indispensable in cancer therapy, particularly for HER2-positive breast cancer, but high treatment costs remain a barrier for many patients. PharmaBlock aims to make world-class, affordable ADC treatments accessible.

The development of TSY-110 involves linking the HER2 monoclonal antibody trastuzumab with a cytotoxic payload. This targeted approach aims to selectively eliminate cancer cells overexpressing HER2 while minimizing systemic toxicity. Pre-clinical assessments and CMC structural characterization indicate a high degree of biosimilarity to the reference product, with a stable drug-antibody ratio (DAR) and comparable pharmacokinetic profiles.

This submission to European regulators follows earlier progress in global approvals. TSY-110 has received orphan drug designation from the US FDA for ET, and gained approval in Taiwan in May and Japan in August for specific ET patient populations. The company is preparing for commercialization, leveraging its existing infrastructure and market presence.

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Submitting this CTA is a major achievement for PharmaBlock and highlights our strategic alliance with Formosa Biologics. Antibody-drug conjugates (ADC) have become indispensable in oncology treatment (including HER2-positive breast cancer care), yet high treatment costs continue to limit cancer patients' access to treatment. Moving TSY-110 into clinical evaluation is a key step toward our global goal of providing oncologists and patients with world-class, affordable ADC treatment options.