Aurobindo Pharma subsidiary CuraTeQ Biologics has received a recommendation for grant of marketing authorisation of biosimilar trastuzumab from a Subject Experts Committee of the Central Drugs Standard Control Organization (CDSCO).
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CuraTeQ was advised to submit Phase IV clinical trial protocol to CDSCO within three months of receiving the marketing authorisation, Aurobindo said on Wednesday in a filing about the SEC decision.
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, the company said. Aurobindo shares closed 2.75% lower at Rs.1,088 each on the BSE.
In July, Aurobindo announced BP02 (Trastuzumab or biosimilar to Herceptin), developed by CuraTeQ had met its primary endpoint in Phase 3 clinical trial. BP02 has shown equivalent efficacy to Herceptin in regard to its clinical response (overall response rate, ORR), in addition to demonstrating a comparable safety profile. “CuraTeQ is in the process of initiating submissions to regulatory agencies starting this quarter. We hope to complete market authorization (MA) application submissions across all key regulated markets in a phased manner, by March 2024,” CEO-Biosimilars, Vaccines and Peptides Satakarni Makkapati had said.