Drug Approval | February 22, 2022
The facility will manufacture its Herceptin biosimilar, Tuznue
Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers
The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients
The license agreement grants Dr. Reddy's the exclusive rights to commercialize the proposed biosimilar in select countries in Latin America and Southeast Asia
It is used for the treatment of advanced colorectal and gastric cancer
The approval is based on a multi-centre, single-arm, open-label pivotal clinical trial
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