COFEPRIS or the Federal Commission for the Protection Against Sanitary Risk is a regulatory body of the Mexican government. It is a decentralized organ of (and supervised by) the Mexican Secretariat of Health, and is responsible for regulating a variety of health related topics in Mexico, including food safety, pharmaceutical drugs, medical devices, organ transplants, and environmental protection.
The approved Trastuzumab biosimilar will be marketed in different strengths. It is used in the treatment of patients with HER2 overexpressing metastatic breast cancer (MBC), HER2 overexpressing early breast cancer (EBC) and advanced gastric cancer.
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.
Dr. Sharvil Patel, managing director, Zydus said: “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 Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
The pharma major reported consolidated net profit of Rs 1,182.3 crore in Q4 FY24 steeply higher than Rs 296.6 crore recorded in Q4 FY23. Revenue from operations jumped 10.44% to Rs 5,533.8 crore during the quarter as compared with Rs 5,010.6 crore posted in corresponding quarter last year.