Zydus Lifesciences secures Mexico’s approval for cancer drug

INDIA— Zydus Lifesciences has reported that Mamitra, a Trastuzumab biosimilar, has been approved for sale in Mexico by the COFEPRIS (Federal Commission for the Protection Against Sanitary Risk).

This approval is a significant step forward for the company as it expands into new areas and provides crucial cancer medicines to more people.

Mamitra will be available in strengths of 150 mg and 440 mg, and it is designed to treat patients with HER2 overexpressing metastatic breast cancer (MBC), HER2 overexpressing early breast cancer (EBC), and advanced gastric cancer.

This approval is particularly timely given the rising prevalence of breast cancer in Mexico, which has recently surpassed prostate and colorectal cancers to become the most diagnosed cancer in the country.

Dr. Sharvil Patel, Managing Director of Zydus, expressed his enthusiasm for this development. He emphasized that the approval of Mamitra in Mexico is a significant advancement in their mission to expand the reach of their biosimilar portfolio.

This move aligns with Zydus’ commitment to providing affordable life-saving therapies, particularly in the field of oncology.

Dr. Patel highlighted that their dedication to science, health, and innovation continues to drive their efforts to meet the unmet healthcare needs of patients worldwide.

Zydus had initially developed and launched the Trastuzumab biosimilar in India in 2016 under the brand name Vivitra.

This development was due to the research team’s efforts at the Zydus Research Centre (ZRC).  

Since its introduction, Vivitra has been a crucial therapy, with an estimated 100,000 patients having received treatment.

Furthermore, Zydus’ success with Mamitra is part of a broader achievement, as the company has already launched twelve life-saving biosimilars in the market.

These efforts reflect Zydus’ unwavering commitment to addressing the critical need for affordable cancer therapies in India and beyond.