Sanofi gets CDSCO panel marketing authorization for Insulin Glargine

New Delhi: Approving the waiver of additional requirements for local clinical trials in the country, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has granted marketing authorization to Sanofi Healthcare India for the Insulin Glargine 100 IU/mL cartridge.

This came in the wake of the proposal presented by Sanofi Healthcare India for marketing authorization for the Insulin Glargine 100 IU/mL cartridge with a request for a waiver for additional requirements for local clinical trials.

This manufacturing of the drug product will be held at an additional site in the country using drug substances imported from Frankfurt, Germany.

Insulin glargine is a modified form of long-acting or basal insulin used to control hyperglycemia in diabetes mellitus. Insulin glargine is produced by recombinant DNA technology utilising Escherichia coli (K12 strain) as the production organism.

Insulin is an important treatment in the management of Type 1 Diabetes (T1D), which is caused by an autoimmune reaction that destroys the beta cells of the pancreas, resulting in the body not being able to produce or synthesise the insulin needed to manage circulating blood sugar levels. As a result, people with T1D rely primarily on exogenous forms of insulin, such as insulin glargine, to lower glucose levels in the blood.

Insulin is also used in the treatment of Type 2 Diabetes (T2D), another form of diabetes mellitus that is a slowly progressing metabolic disorder caused by a combination of genetic and lifestyle factors that promote chronically elevated blood sugar levels. 

Insulin glargine was reformulated by Sanofi as the product Toujeo in an extra-concentrated form containing 300IU/mL.

Toujeo was first approved in 2015 in the United States and, since then, has been approved in over 65 countries worldwide. Toujeo™ is a prescription drug and is available in the newly designed SoloSTAR® pen. 

Earlier, the Medical Dialogues Team had reported that the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) had rejected the Sanofi India Limited's proposal for marketing authorization of the antidiabetic fixed ratio combination of Insulin Glargine and Lixisenatide (100 U + 50 g/33 g).

Moving further, at the 79th SEC meeting for Endocrinology & Metabolism held on 21.09.2021 at CDSCO, the expert panel extensively evaluated the drug maker Sanofi Healthcare India's proposal for marketing authorization for the Insulin Glargine 100 IU/mL cartridge with a request for a waiver for additional requirements for local clinical trial.

After detailed deliberation, the Committee recommended the grant of marketing authorization with a waiver of the additional requirement for local clinical trials in the country.