Aurobindo Pharma arm bags CDSCO panel recommendation for grant of marketing authorization of biosimilar trastuzumab
Hyderabad: In a recent BSE filing, Aurobindo Pharma has announced that CuraTeQ Biologics Pvt. Ltd., a wholly owned subsidiary of the Company, has received a recommendation from Subject Experts Committee (SEC) operating under the aegis of CDSCO (Central Drugs Standard Control Organization) 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.
Medical Dialogues team had earlier reported that the breast cancer biosimilar product, BP02 (Trastuzumab or biosimilar to Herceptin), developed by Curateq Biologics Private Limited had met its primary endpoint in Phase 3 clinical trial (Trial No.: CR201-18).
Read also: Breast cancer biosimilar product meets primary endpoint in Phase 3 clinical trial: Aurobindo Pharma
Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded speciality pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 25 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA. The company’s product portfolio is spread over seven major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.
Read also: Aurobindo Pharma arm bags USFDA nod for Posaconazole Injection
