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    DRUG:

    Ujvira (trastuzumab emtansine biosimilar)

    i
    Other names: ZRC-3256
    Company:
    Zydus Lifesciences
    Drug class:
    Microtubule inhibitor, HER2-targeted antibody-drug conjugate
    Related drugs:
    23d
    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
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Kadcyla (ado-trastuzumab emtansine) • Ujvira (trastuzumab emtansine biosimilar)
    over2years
    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.
    Retrospective data • Real-world evidence • Real-world • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Kadcyla (ado-trastuzumab emtansine) • Ujvira (trastuzumab emtansine biosimilar)
    over4years
    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 • PK/PD data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Kadcyla (ado-trastuzumab emtansine) • Ujvira (trastuzumab emtansine biosimilar) • SIBP-01 (trastuzumab biosimilar)