Zydus Lifesciences has received marketing approval from Mexico’s Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) for its Trastuzumab biosimilar, Mamitra.
The company in a press statement on Wednesday informed that this new approval allows Mamitra to be marketed in strengths of 150 mg and 440 mg, targeting HER2 overexpressing metastatic breast cancer (MBC), HER2 overexpressing early breast cancer (EBC), and advanced gastric cancer.
Breast cancer has now surpassed prostate and colorectal cancers as the most diagnosed cancer in Mexico. Sharvil Patel, Managing Director of Zydus, commented, “The approval of Mamitra in Mexico marks a significant milestone for our biosimilar portfolio, enabling us to reach new markets and offer affordable, life-saving therapies, particularly in the field of oncology. Our dedication to science, health, and innovation allows us to address the unmet healthcare needs of patients worldwide.”
Mamitra was initially developed by Zydus’s research team at the Zydus Research Centre (ZRC) and launched in India in 2016 under the brand name Vivitra. Since its launch, the therapy has benefited an estimated 100,000 patients, the press statement from the company added.
