Aurobindo Arm CuraTeQ Clears Key CDSCO Hurdle for Bevacizumab Cancer Biosimilar
New Delhi: CuraTeQ Biologics Private Limited has received recommendation from the Subject Expert Committee (SEC), CDSCO, for grant of permission to manufacture and market Bevacizumab concentrate for solution for infusion 25 mg/mL (100 mg/4 mL and 400 mg/16 mL vial, r-DNA origin) for metastatic colorectal cancer, based on comparative Phase I and Phase III clinical trial data generated in India, subject to the condition that the firm conducts a Phase IV clinical trial and submits the protocol to CDSCO within three months of grant of marketing authorization.
The company presented clinical data from Phase I and Phase III studies conducted in Indian patients with metastatic colorectal cancer to support its application.
After detailed deliberation, the committee found the evidence adequate to recommend approval while mandating post-marketing surveillance through a Phase IV study.
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