Ahmedabad, India, 31 July 2024 – Zydus Lifesciences Limited has announced that the Mexican regulatory authority, COFEPRIS (Federal Commission for the Protection Against Sanitary Risk), has granted marketing approval for Mamitra™, a Trastuzumab biosimilar. This approval allows Zydus to market Mamitra™ in Mexico, expanding its reach in the global oncology market.
Mamitra™ will be available in two strengths, 150 mg and 440 mg, and is indicated for the treatment of patients with HER2 overexpressing metastatic breast cancer (MBC), HER2 overexpressing early breast cancer (EBC), and advanced gastric cancer. This approval is particularly significant as breast cancer has now become the most diagnosed cancer in Mexico, surpassing prostate and colorectal cancers.
Dr. Sharvil Patel, Managing Director of Zydus, expressed his enthusiasm about the approval: "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 first developed and launched the Trastuzumab biosimilar in India under the brand name Vivitra in 2016. Since then, it has been used to treat approximately 100,000 patients. With a strong focus on affordable healthcare, Zydus has already introduced twelve lifesaving biosimilars to the market, significantly contributing to the fight against cancer in India.
Zydus Lifesciences Ltd. is a global lifesciences company dedicated to discovering, developing, manufacturing, and marketing a broad range of healthcare therapies. With a workforce of 26,000 employees worldwide, including 1,400 scientists in R&D, Zydus is driven by a mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The company has been at the forefront of introducing innovative, first-in-class products in the market, addressing unmet healthcare needs through vaccines, therapeutics, biologicals, and biosimilars.
Zydus’s approval of Mamitra™ in Mexico represents another step forward in its mission to provide affordable and accessible healthcare to patients worldwide, particularly in the field of oncology.
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