Zydus Lifesciences Ltd on Wednesday said the Mexican regulatory authority has granted marketing approval for Mamitra, a Trastuzumab biosimilar used to treat various types of cancer. Following the approval by Mexican regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk), for Mamitra, the drug will be marketed in different strengths of 150 mg and 440 mg, Zydus Lifesciences said in a regulatory filing. The product is used in the treatment of breast cancer and advanced gastric cancer. Breast cancer has become the most diagnosed cancer in Mexico, overtaking prostate and colorectal cancers, the company added.
“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,” Zydus Managing Director, Dr Sharvil Patel said.
Developed in-house by the research team at the Zydus Research Centre (ZRC), the Trastuzumab biosimilar was launched in 2016 in India under the brand name Vivitra. Since then, an estimated 1 lakh patients have been treated with the therapy, the company added.
