Zydus Lifesciences Ltd has recently announced that its Trastuzumab biosimilar, Mamitra, has received marketing approval from Mexico’s regulatory authority, COFEPRIS (Federal Commission for the Protection Against Sanitary Risk). This approval represents a significant expansion of Zydus’s biosimilar portfolio, allowing Mamitra to be marketed in Mexico in two strengths: 150 mg and 440 mg. Mamitra is intended to treat patients with HER2 overexpressing metastatic breast cancer (MBC), HER2 overexpressing early breast cancer (EBC), and advanced gastric cancer.
Breast cancer has become the most commonly diagnosed cancer in Mexico, surpassing both prostate and colorectal cancers. This shift underscores the importance of introducing Mamitra at this time, as it addresses a critical need for effective and affordable cancer therapies in the region. The availability of Mamitra in Mexico aims to provide more accessible treatment options for patients battling these challenging conditions.
Mamitra was originally developed and launched in India under the brand name Vivitra by the Zydus Research Centre (ZRC) in 2016. Since its introduction, Vivitra has been successfully used to treat approximately 100,000 patients in India. This biosimilar has been part of Zydus’s broader effort to address the growing demand for affordable cancer treatments, reflecting the company’s commitment to improving healthcare accessibility.
The approval of Mamitra in Mexico aligns with Zydus Lifesciences’ broader strategy to expand its biosimilar offerings into international markets. Sharvil Patel, Managing Director of Zydus Lifesciences, emphasized that the approval of Mamitra in Mexico marks an important milestone for the company. He noted that it allows Zydus to extend its biosimilar portfolio to new markets, enhancing the availability of affordable, life-saving oncology treatments. Patel underscored that Zydus’s dedication to science, health, and innovation continues to drive its efforts to meet global healthcare needs.
Zydus Lifesciences has a history of launching lifesaving biosimilars, with twelve such products already in its portfolio, aimed at addressing critical healthcare needs. The company’s commitment to providing affordable and effective cancer therapies is evident in its global expansion efforts and the introduction of Mamitra to the Mexican market. This move not only supports the company’s mission to improve access to essential treatments but also reinforces its role as a key player in the global biosimilar industry.
SOURCE:
INDIA INFO LINE
