CuraTeQ Biologics receives recommendation for grant of marketing authorization of 'biosimilar trastuzumab'

Trastuzumab biosimilar is a humanized monoclonal antibody for treating metastatic breast cancer

CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, received from Subject Experts Committee (SEC) operating under the aegis of CDSCO (Central Drugs Standard Control Organization) a recommendation for grant of marketing authorization of biosimilar trastuzumab.

Trastuzumab biosimilar, supplied in single dose glass vials containing 150 mg and 420 mg lyophilized powder for concentrate for solution for infusion, is a humanized monoclonal antibody for treating metastatic breast cancer and early breast cancer that is human epidermal growth factor receptor 2 positive.

CuraTeQ was asked to submit Phase IV clinical trial protocol to CDSCO within three months of receiving the marketing authorization.