Zydus Lifesciences gets Mexican marketing approval for Mamitra to treat various cancers
Ahmedabad: 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.
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.
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Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Zydus has been actively discovering and developing New Chemical Entities (NCEs) novel biologicals, several biosimilars and vaccines as a part of its innovation pipeline. Over the last decade, Zydus has introduced several products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars.
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