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 CureTeQ 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.
Earlier this month, Aurobindo Pharma’s manufacturing facility located in Sangareddy district of Telangana, was classified as ‘voluntary action indicated’ after inspection by the United States Food and Drug Administration (USFDA).
In another development, Aurobindo Pharma is reportedly exploring the options for the launch of initial public offering (IPO) of its wholly-owned subsidiary, speciality generic firm Eugia Pharma Specialities, to raise around ₹4,500 crore in 2024.
The Hyderabad-based company had previously attempted the sale of Eugia and held discussions with top private equity players in 2022, but the negotiations did not fructify into an eventual deal due to differences over valuations.
Shares of Aurobindo Pharma were trading 2.3% lower at ₹1,093.35 per piece on BSE at 12:50pm.
