Biocad has opened patient enrollment for a Phase III clinical trial of BCD-237 (trastuzumab emtansine), a potential biosimilar of Swiss drugmaker Hoffmann-La Roche’s original Kadcyla.
The drug is designed to treat locally advanced unresectable or metastatic HER2-positive breast cancer. According to Russia’s state drug registry, Kadcyla remains the only product with that international nonproprietary name registered in the country.
The study aims to demonstrate comparable efficacy, safety and immunogenicity profiles for BCD-237 versus the original drug following repeated intravenous administration.
A total of 488 female patients aged 18 and older with confirmed diagnosis will take part. All have experienced disease progression while receiving trastuzumab and taxane therapy or within six months after treatment.
The trial will be conducted at 48 clinical centres, including 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.
The company expects to complete the study by the end of 2031.
Trastuzumab emtansine is an antibody-drug conjugate (ADC) that targets the HER2 receptor.
The original Kadcyla was approved in the United States in 2013 for HER2-positive breast cancer, becoming the first ADC cleared for that indication. It remained the standard of care until 2022, when a more potent rival – Enhertu (trastuzumab deruxtecan) from AstraZeneca and Daiichi Sankyo – entered the U.S. market.
In Russia, the original Kadcyla was registered 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. Purchases totalled roughly 11.4 million roubles, a 41.1% increase from 2024.
