Russia's Biocad Initiates Phase III Trial of Kadcyla Biosimilar BCD-237 for HER2-Positive Breast Cancer
Key Insights
Biocad has opened patient enrollment for a Phase III trial comparing its trastuzumab emtansine biosimilar BCD-237 (search) against Roche's original Kadcyla in HER2-positive breast cancer (search).
The study will enroll 488 female patients across 48 clinical centers in Russia, with completion expected by the end of 2031.
Kadcyla remains the only trastuzumab emtansine product registered in Russia and ranked among the top five hospital procurement drugs by value in 2025.
Russian biotechnology company Biocad has opened patient enrollment for a Phase III clinical trial of BCD-237 (search), a proposed biosimilar to Roche's Kadcyla (trastuzumab emtansine), targeting patients with locally advanced unresectable or metastatic HER2-positive breast cancer (search). The trial represents the final stage of clinical development for the domestic antibody-drug conjugate (ADC) in a market where Kadcyla remains the sole registered product with that international nonproprietary name.
The study is designed to demonstrate comparable efficacy, safety, and immunogenicity profiles for BCD-237 (search) versus the original Kadcyla following repeated intravenous administration. A total of 488 female patients aged 18 and older with confirmed HER2-positive breast cancer (search) will participate. All eligible patients must have experienced disease progression while receiving trastuzumab and taxane therapy, or within six months after completing such treatment.
The trial will be conducted across 48 clinical centers throughout Russia, including several of the country's leading oncology institutions: the Blokhin National Medical Research Centre of Oncology in Moscow, the Rostov National Medical Research Centre of Oncology, and the Petrov National Medical Research Centre of Oncology in St. Petersburg. Biocad expects to complete the study by the end of 2031.
Kadcyla's Position in the Russian Market
Kadcyla was registered in Russia in 2014 and is included in the national list of vital and essential medicines. According to analytics firm DSM Group, Kadcyla ranked among the top five brands in the hospital procurement segment by value in 2025, with purchases totaling approximately 11.4 million roubles — a 41.1% increase from 2024. This growing demand underscores the clinical need that a biosimilar could address, potentially improving access and reducing costs within the Russian healthcare system.
Scientific Background and Global Context
Trastuzumab emtansine is an antibody-drug conjugate that targets the HER2 (search) receptor, combining the monoclonal antibody trastuzumab with a cytotoxic microtubule inhibitor. The original Kadcyla was approved in the United States in 2013 for HER2-positive breast cancer (search), becoming the first ADC cleared for that indication. It remained the standard of care until 2022, when Enhertu (trastuzumab deruxtecan) from AstraZeneca and Daiichi Sankyo entered the U.S. market as a more potent rival.
Despite the emergence of newer ADCs globally, Kadcyla retains its position in Russia, where it remains the only trastuzumab emtansine product available. Biocad's BCD-237 (search) aims to provide a domestic alternative, potentially reshaping the treatment landscape for Russian patients with HER2-positive breast cancer (search) who have progressed on prior trastuzumab and taxane-based regimens.