Ujvira (trastuzumab emtansine biosimilar) / Zydus Lifesciences - LARVOL DELTA

Real-World Safety and Efficacy of Biosimilar Trastuzumab Emtansine (T-DM1) in HER2-Positive Breast Cancer: A Prospective Single-Institution Study From India. (PubMed, Int J Breast Cancer) - "T-DM1 biosimilar showed outcomes consistent with those reported for the originator in real-world settings, supporting its broader adoption in both early and advanced HER2-positive breast cancer. Its affordability may improve access and outcomes in resource-limited settings."

Journal • Real-world evidence • Breast Cancer • Fatigue • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Thrombocytopenia • HER-2

Real-world efficacy and safety of trastuzumab emtansine (T-DM1 Biosimilar, Ujvira) in early and metastatic HER2-positive breast cancer: A multicentre pooled retrospective analysis from India (ESMO-TAT 2026) - "This pooled real-world analysis demonstrates that T-DM1 biosimilar therapy is feasible, safe, and clinically effective in both adjuvant and metastatic HER2-positive breast cancer, with outcomes consistent with pivotal clinical trials, supporting improved access in resource-limited settings."

Metastases • Real-world • Real-world effectiveness • Real-world evidence • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Real-world outcomes of a trastuzumab emtansine (T-DM1) biosimilar (Ujvira) in early-stage HER2-positive breast cancer: A single-centre retrospective study from India (ESMO-TAT 2026) - "In this real-world post-neoadjuvant cohort, a trastuzumab emtansine biosimilar demonstrated encouraging short-term IDFS and a manageable safety profile, consistent with expectations from pivotal trial data and supporting its feasibility as a cost-effective adjuvant option in routine practice."

Real-world • Real-world evidence • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Real-world evaluation of a trastuzumab emtansine biosimilar in metastatic HER2-positive breast cancer: A single-centre retrospective analysis from India (ESMO Asia 2025) - "All patients had prior trastuzumab exposure; many were heavily pretreated (taxanes 84.3%, anthracyclines 62.7%, pertuzumab 19.6%, lapatinib 39.2%). This analysis supports the trastuzumab emtansine biosimilar as an effective, well-tolerated option for metastatic HER2-positive breast cancer, demonstrating a meaningful ORR and manageable toxicity profile, with PFS broadly consistent across subgroups. Confirmation in larger studies is warranted."

HEOR • Metastases • Real-world • Real-world evidence • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Real-world data on the efficacy of T-DM1 biosimilar for the treatment of HER2-positive metastatic breast cancer patients: Outcomes from a single center retrospective study in India (ESMO Asia 2023) - "Conclusions The study findings suggested that T-DM1 is effective in managing HER2-positive metastatic breast cancer and the outcomes with T-DM1 biosimilar usage in the real world are consistent with the published evidence of randomized controlled clinical trials with T-DM1. So, this biosimilar can be a reasonable option in routine clinical practice in India."

Metastases • Real-world • Real-world evidence • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Comparison of the Efficacy, Safety, Pharmacokinetic and Immunogenicity of UJVIRA (ZRC-3256, Trastuzumab Emtansine) With the Kadcyla (Trastuzumab Emtansine) in the Treatment of HER2-Positive Metastatic Breast Cancer: A Randomized, Open-Label, Multicenter Study in India. (PubMed, Clin Breast Cancer) - "Results demonstrated biosimilarity between UJVIRA and Kadcyla in terms of efficacy, safety, pharmacokinetics, and immunogenicity. Therefore, UJVIRA could prove to be a cost-effective treatment alternative for HER2-positive metastatic breast cancer patients in India."

Clinical • Journal • PK/PD data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Improving Outcomes in Patients With HER2+ Metastatic Breast Cancer: Applying Evidence to Clinical Practice - Episode 12 Expert Perspectives on Updates in HER2+ BC Presented at the 2022 ASCO Annual Meeting (Cancer Network) - "Erika Hamilton, MD: Tiffany, what data from this year's [2022] ASCO [American Society of Clinical Oncology] [Annual Meeting] may have been most compelling in HER2 [human epidermal growth factor receptor 2]-positive [disease]? [What have] you seen that's piqued your interest?....Erika Hamilton, MD: As I was reflecting on DESTINY-Breast04 [NCT03734029], which is a little off topic, but I feel like [for] the past 2 decades, we've [been] subsetting, profiling, and figuring out who gets what, and then a drug comes along. Now I'm thinking, 'Well, should we just give it to everybody? Do we really need to be testing for the [immunohistochemistry]?' It's kind of full circle."

Video

’New Standard of Care’ for HER2-Mutant NSCLC? (Medscape) - "'These results establish the new standard of care for patients with NSCLC harboring HER2 mutations,' Antonio Passaro, MD, PhD...write in an accompanying editorial. The findings 'appear robust and potentially could extend to patients who have not previously received systemic treatment.'"

Media quote

Zydus Launches First Kadcyla Biosimilar in India At Sharp Discount (Scripintelligence) - "Another In Works From Hetero..."

Launch non-US • Breast Cancer • Oncology

Zydus Cadila announces launch of Ujvira for Breast Cancer Treatment (ET Healthworld) - "Zydus Cadila, on Monday, announced the launch of Trastuzumab Emtansine, the first antibody Drug Conjugate (ADC) biosimilar for early and advanced HER2 positive Breast Cancer Patients' treatment...The drug has been launched under the brand name ‘Ujvira’ and has been priced at Rs. 32495 for a 100 mg vial....Ujvira will be available in two strengths, 100 mg and 160 mg, the company said. The company stated that ‘Ujvira’ has been priced at nearly 80 percent less than the market price."

Launch non-US • Pricing • Breast Cancer • HER2 Positive Breast Cancer • Oncology