Zydus Lifesciences secures COFEPRIS approval to market MamitraTM in Mexico for cancer treatment

With the approval of MamitraTM, Zydus aims to provide affordable cancer treatments for HER2-positive breast and gastric cancer patients

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New Delhi: Zydus Lifesciences Limited announced that it has received marketing approval from regulatory authority COFEPRIS, Mexico’s Federal Commission for the Protection Against Sanitary Risk, for MamitraTM, its Trastuzumab biosimilar.
The approval allows Zydus to market MamitraTM in Mexico in two strengths, 150 mg and 440 mg, for treating patients with HER2 overexpressing metastatic breast cancer (MBC), HER2 overexpressing early breast cancer (EBC), and advanced gastric cancer.
Breast cancer is now the most diagnosed cancer in Mexico, surpassing prostate and colorectal cancers. The introduction of MamitraTM aims to provide patients with an affordable and effective treatment option.  
Dr. Sharvil Patel, Managing Director of Zydus, stated, “The approval of MamitraTM 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 initially developed and launched the Trastuzumab biosimilar under the brand name Vivitra in India by the research team at the Zydus Research Centre (ZRC) in 2016. Since then, approximately 100,000 patients have been treated with the therapy. With twelve lifesaving biosimilars already on the market, Zydus continues to address the need for affordable cancer therapies in India and now expands its reach to the Mexican market.