COFEPRIS grants marketing approval for Mamitra? (Trastuzumab biosimilar)
Zydus Lifesciences announced that the Mexican regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk), has granted marketing approval for Mamitra™, a Trastuzumab biosimilar. The drug will be marketed in different strengths of 150 mg and 440 mg and used in the treatment of patients with HER2 overexpressing metastatic breast cancer (MBC), HER2 overexpressing early breast cancer (EBC) and advanced gastric cancer. Breast cancer has become the most diagnosed cancer in Mexico, overtaking prostate and colorectal cancers.
Zydus had developed and launched the Trastuzumab biosimilar developed in-house by the research team at the Zydus Research Centre (ZRC) in 2016 in India under the brand name Vivitra. Since then, an estimated 1,00,000 patients have been treated with the therapy. With twelve lifesaving biosimilars already launched in the market, Zydus has been bridging the unmet need for affordable therapies in the fight against cancer in India.
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