Aurobindo Pharma Ltd’s wholly-owned subsidiary, CuraTeQ Biologics Private Ltd, on Wednesday, January 17, received marketing authorisation from the Central Drugs Standard Control Organization (CDSCO) for biosimilar trastuzumab.
In a stock exchange filing, Aurobindo Pharma said that CuraTeQ Biologics received a recommendation for grant of marketing authorisation of biosimilar trastuzumab from the Subject Experts Committee (SEC) of CDSCO, the apex drug regulator in India.
Trastuzumab biosimilar is a humanised monoclonal antibody that is used in the treatment of metastatic breast cancer and early breast cancer.
This monoclonal antibody is supplied in single dose glass vials that contain lyophilized powder in the dosages of 150 mg and 420 mg as concentrate for solution for infusion, Aurobindo Pharma informed the bourses.
CuraTeQ was asked to submit Phase IV clinical trial protocol to CDSCO within three months of receiving the marketing authorisation.
Article excerpt reposted from cnbctv18.com
