On 31 July 2024, Zydus Lifesciences announced it has received approval from the Mexican Regulatory Authority, COFEPRIS, to market Mamitra™, biosimilar to Roche’s Herceptin® (trastuzumab), for HER2+ metastatic and early breast cancer and advanced gastric cancer.
The first trastuzumab biosimilar was approved in the US in December 2017 and in the EU in November 2017.
MamitraTM is the second Zydus biosimilar to be approved in Mexico this month, with the announcement of Mexican approval for its bevacizumab biosimilar BhavaTM on 22 July 2024.