NEW DELHI: Zydus Lifesciences Ltd introduced on Wednesday that Mamitra, a Trastuzumab biosimilar used to deal with numerous forms of most cancers, has been granted advertising and marketing approval by the Mexican regulatory authority.
Mamitra is used within the remedy of breast most cancers and superior gastric most cancers. The corporate famous that breast most cancers has surpassed prostate and colorectal cancers to develop into essentially the most recognized most cancers in Mexico.
“The approval of Mamitra in Mexico permits us to develop the attain of our biosimilar portfolio to newer markets and allow entry to reasonably priced life-saving therapies, significantly in oncology,” stated Dr Sharvil Patel, managing director of Zydus.
The approval, given by COFEPRIS (Federal Fee for the Safety Towards Sanitary Danger), permits the drug to be marketed in several strengths of 150 mg and 440 mg, as per the corporate’s regulatory submitting.
The Trastuzumab biosimilar was developed in-house by the analysis crew on the Zydus Analysis Centre (ZRC) and launched in India in 2016 underneath the model identify Vivitra. Since its launch, an estimated 1 lakh sufferers have been handled with the remedy, in keeping with the corporate.
Mamitra is used within the remedy of breast most cancers and superior gastric most cancers. The corporate famous that breast most cancers has surpassed prostate and colorectal cancers to develop into essentially the most recognized most cancers in Mexico.
“The approval of Mamitra in Mexico permits us to develop the attain of our biosimilar portfolio to newer markets and allow entry to reasonably priced life-saving therapies, significantly in oncology,” stated Dr Sharvil Patel, managing director of Zydus.
The approval, given by COFEPRIS (Federal Fee for the Safety Towards Sanitary Danger), permits the drug to be marketed in several strengths of 150 mg and 440 mg, as per the corporate’s regulatory submitting.
The Trastuzumab biosimilar was developed in-house by the analysis crew on the Zydus Analysis Centre (ZRC) and launched in India in 2016 underneath the model identify Vivitra. Since its launch, an estimated 1 lakh sufferers have been handled with the remedy, in keeping with the corporate.
