Zydus Lifesciences (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) 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.
Speaking on the development, Dr Sharvil Patel, Managing Director, Zydus said, “The approval of Mamitra in Mexico allows us to expand the reach of our biosimilar portfolio to newer markets and enable access to affordable life-saving therapies, particularly in oncology. Our commitment to science, health and innovation helps us bridge unmet healthcare needs of patients globally.”
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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