Zydus Lifesciences Receives Marketing Approval for Mamitra in Mexico

31 Jul 2024 , 11:49 AM

Zydus Lifesciences has announced that Mamitra, a Trastuzumab biosimilar, has received marketing approval from COFEPRIS (Federal Commission for the Protection Against Sanitary Risk) in Mexico. This approval marks a significant milestone for Zydus as Mamitra will now be available in two strengths: 150 mg and 440 mg. The drug is intended for the treatment of patients with HER2 overexpressing metastatic breast cancer (MBC), HER2 overexpressing early breast cancer (EBC), and advanced gastric cancer.

Breast cancer is now the most frequently diagnosed cancer in Mexico, surpassing prostate and colorectal cancers, making the introduction of Mamitra particularly timely and relevant.

Mamitra was initially developed and launched in India in 2016 under the brand name Vivitra by the research team at Zydus Research Centre (ZRC). Since its launch, the Trastuzumab biosimilar has treated approximately 100,000 patients in India. Zydus Lifesciences has previously launched twelve lifesaving biosimilars, addressing the critical need for affordable cancer therapies in India.

Sharvil Patel, Managing Director of Zydus, said on approval that, “The approval of Mamitra in Mexico allows us to expand the reach of our biosimilar portfolio to newer markets and provide access to affordable, life-saving therapies, especially in oncology.” She added, “Our dedication to science, health, and innovation continues to drive our efforts to meet the global healthcare needs of patients.”