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

New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted permission to GeneSys Biologics 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.

However, the nod is subject to the condition that the firm should conduct a Phase IV study in the country.

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.