A retrospective analysis of 101 patients treated across seven oncology centers in India reports real-world outcomes for UJVIRA, a biosimilar of the antibody-drug conjugate trastuzumab emtansine (T-DM1), in HER2-positive breast cancer. The study, published in Breast Cancer Research and Treatment, covered patients treated between October 2021 and July 2025 and is among the sparse real-world datasets on this biosimilar from India.
It is approved in two settings: the adjuvant setting for patients who have residual disease after neoadjuvant chemotherapy and surgery, and the metastatic setting for HER2-positive breast cancer. The biosimilar UJVIRA offers a lower-cost alternative, but until now real-world evidence from India has remained limited.
The pooled analysis divided patients into two cohorts. The adjuvant cohort comprised 19 patients with residual disease after neoadjuvant therapy and surgery. The metastatic cohort comprised 82 patients who had progressed on trastuzumab-chemotherapy regimens. The primary endpoints were invasive disease-free survival in the adjuvant cohort and progression-free survival in the metastatic cohort, with overall survival and safety as secondary endpoints.
In the adjuvant cohort, with a median follow-up of 19 months, the median invasive disease-free survival had not been reached; the mean was 14.6 months, and only two events, or 10.5 percent of patients, had occurred. In the metastatic cohort, with a median follow-up of 8 months, the median progression-free survival was 7.5 months, with a mean of 8.3 months; 61 events, or 74.4 percent of patients, were recorded.
Timing of treatment appeared to matter in the metastatic setting. Progression-free survival was longer when T-DM1 was administered earlier in the treatment sequence: 28 months when given as first-line therapy, 9 months as second-line, and 8 months as third- or fourth-line therapy. The researchers noted this difference with a p-value of 0.06, which does not reach conventional statistical significance, so the trend should be interpreted with caution.
Overall survival in the metastatic cohort was 15.5 months, rising to 36 months among patients who received T-DM1 as first-line treatment. Because the analysis is retrospective and observational, these figures describe outcomes in the patients treated and cannot by themselves establish causal effects of treatment timing or prove superiority over alternatives.
Safety findings differed between the two cohorts. In the adjuvant cohort, no grade 3 or grade 4 events were reported. The authors characterize the overall safety profile as acceptable.
The study’s authors conclude that UJVIRA demonstrated real-world clinical effectiveness and an acceptable safety profile in both adjuvant and metastatic HER2-positive breast cancer, with outcomes they describe as similar to those seen in the landmark clinical trials that established T-DM1, supporting its role as a cost-effective biosimilar option in India.
Several limitations shape how these results should be read. The analysis is retrospective, the adjuvant cohort is small at 19 patients, and follow-up in the metastatic cohort was relatively short at a median of 8 months. The reported survival figures are therefore early estimates that may change with longer follow-up. Nevertheless, the dataset adds real-world evidence from India, where affordable biosimilars can broaden access to targeted therapies for HER2-positive breast cancer.
Subject of Research: Real-world efficacy and safety of the trastuzumab emtansine biosimilar UJVIRA in HER2-positive breast cancer in India
Article Title: Real-world efficacy and safety of trastuzumab emtansine biosimilar (UJVIRA®) in early and metastatic HER2-positive breast cancer: a multicenter pooled retrospective analysis from India
Article References: Mahajan, A., Panda, S. S., Moharana, L., Chandrakanth, M. V., Agarwala, V., Manna, R., Saju, S. V., Raju, S. H., Ganesan, P., Shankar, G., Phillip, A. O., Cyriac, S. L., Jose, A., Unnikrishnan, P., Bhatia, K. P., Sehrawat, A., Sundriyal, D., Dhanai, H., Samantaray, L., … Dubashi, B. (2026). Real-world efficacy and safety of trastuzumab emtansine biosimilar (UJVIRA®) in early and metastatic HER2-positive breast cancer: a multicenter pooled retrospective analysis from India. Breast Cancer Research and Treatment, 220(1), Article 20. https://doi.org/10.1007/s10549-026-08114-0
Image Credits: AI Generated
DOI: 10.1007/s10549-026-08114-0
Keywords: HER2-positive breast cancer, trastuzumab emtansine, biosimilar, UJVIRA, adjuvant therapy, metastatic breast cancer, progression-free survival, India, real-world evidence, thrombocytopenia, antibody-drug conjugate, Real-world
News Source: Nathaniel Bowman. (October 29, 2026). Trastuzumab emtansine biosimilar shows real-world results in HER2-positive breast cancer in India. Scienmag.
