GeneSys Biologics Gets SEC Nod to Market Insulin Glargine, Phase IV Study Mandated

This came after the firm presented the proposal to manufacture and market the drug product Insulin Glargine I.P. (r-DNA Origin) Injection 100 IU/ml based on the results of the Phase III clinical trial conducted by the firm.

Insulin glargine is a long-acting insulin used to treat type 1 and type 2 diabetes in certain patients to improve and maintain blood glucose levels. Insulin glargine is a man-made form of human insulin that is used once daily to provide a base level of insulin that keeps working for 24 hours or longer.

At the recent SEC meeting, the committee noted that the firm has conducted Non-Inferiority study to compare the Efficacy and Safety of GEN1501 (Insulin Glargine (r-DNA Origin) Injection 100 Units/mL) of GeneSys Biologics, India, with LANTUS (Insulin Glargine (r-DNA Origin) Injection 100 Units/mL) in subjects with Type 2 Diabetes Mellitus on Uncontrolled Oral Antidiabetic therapy (OAD).

After detailed deliberation, the committee recommended the grant of permission to the firm to manufacture and market Insulin Glargine I.P. (r-DNA Origin) Injection 100 IU/ml for the “Treatment of Type II Diabetes Mellitus in Adults only” with a condition to conduct a Phase IV study in the country.

Accordingly, the expert panel suggested that the protocol to conduct the Phase IV study shall be submitted to CDSCO within 3 months of the grant of marketing authorization permission to manufacture and market the drug product.