NEW DELHI: Zydus Lifesciences Ltd announced on Wednesday that Mamitra, a Trastuzumab biosimilar used to treat various types of cancer, has been granted marketing approval by the Mexican regulatory authority.
Mamitra is used in the treatment of breast cancer and advanced gastric cancer. The company noted that breast cancer has surpassed prostate and colorectal cancers to become the most diagnosed cancer in Mexico.
“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,” said Dr Sharvil Patel, managing director of Zydus.
The approval, given by COFEPRIS (Federal Commission for the Protection Against Sanitary Risk), allows the drug to be marketed in different strengths of 150 mg and 440 mg, as per the company’s regulatory filing.
The Trastuzumab biosimilar was developed in-house by the research team at the Zydus Research Centre (ZRC) and launched in India in 2016 under the brand name Vivitra. Since its launch, an estimated 1 lakh patients have been treated with the therapy, according to the company.
Mamitra is used in the treatment of breast cancer and advanced gastric cancer. The company noted that breast cancer has surpassed prostate and colorectal cancers to become the most diagnosed cancer in Mexico.
“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,” said Dr Sharvil Patel, managing director of Zydus.
The approval, given by COFEPRIS (Federal Commission for the Protection Against Sanitary Risk), allows the drug to be marketed in different strengths of 150 mg and 440 mg, as per the company’s regulatory filing.
The Trastuzumab biosimilar was developed in-house by the research team at the Zydus Research Centre (ZRC) and launched in India in 2016 under the brand name Vivitra. Since its launch, an estimated 1 lakh patients have been treated with the therapy, according to the company.
