On 10 June 2026, GxP News reported that Biocad has commenced patient enrolment for a phase 3 clinical trial of BCD-237 (trastuzumab emtansine), biosimilar to Genentech’s Kadcyla®, for treatment of locally advanced unresectable or metastatic HER2 positive breast cancer.
The phase 3 trial is being conducted in 48 clinical centres in Russia and is expected to be completed by the end of 2031. The study will assess the efficacy, safety and immunogenicity profiles for BCD-237 against Kadcyla® following repeated intravenous administration.
Kadcyla® was first approved in the US in February 2013 and is now approved in over 100 countries. The first reported Kadcyla® biosimilar was Zydus’ Ujvira®, which was launched in India in May 2021. Trastuzumab emtansine biosimilars are also in development by Formosa Pharmaceuticals (TSY-110, co-developed with EirGenix), which is aiming to become the first to have a Kadcyla® biosimilar launched in regulated markets like the US and EU. with clinical trials expected to commence in 2026, and Zhejiang Hisun Pharmaceutical (HS630), which reported results of a nonclinical study of the biosimilar in 2025.