The decision was taken at the SEC meeting held on August 20, 2025, at CDSCO headquarters in New Delhi.
Virchow Biotech presented pre-clinical study reports, a bioequivalence study protocol (Protocol No.: AR089-25, Version No.: 01, dated 09.05.2025) and a Phase-III clinical trial protocol (Protocol No.: VBSEMA-DM/2025-CT1, Version No.: 1, dated 05.05.2025) for type 2 diabetes mellitus.
After detail deliberation, the Committee recommended for grant of permission to conduct the BE study and Phase III clinical trial with following change in the CT protocol:
1. Fasting and postprandial blood sugar levels should be used for dose titration.
2. Thyroid screening for Medullary carcinoma Thyroid by Ultrasound should be part of screening for subject eligibility.
3. Caution for Medullary Thyroid carcinoma (MTC) should be part of Informed Consent Form.
Further, the firm was asked to submit BE Study report to CDSCO, adding that the "BE report should be evaluated from the committee before initiation of Phase-III clinical trial."
Semaglutide is a GLP-1 receptor agonist that lowers blood sugar and supports weight reduction in type 2 diabetes patients. It has a once-weekly dosing schedule, making it a widely adopted therapy internationally. The BE and Phase III trials are essential steps in confirming comparability and clinical efficacy before the product can be introduced in India.
Virchow Biotech is an Indian biopharmaceutical company engaged in biosimilar development, vaccine production, and complex generics.
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