Biocon Biologics gets CDSCO panel nod to import, manufacture Insulin Aspart Injection
New Delhi: Approving the waiver of Phase III clinical trial in the country, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has given its nod to pharmaceutical major Biocon Biologics to import and market the Insulin Aspart Injection for the treatment of the diabetic condition.
However, this approval is subjected to the condition that the firm should conduct Phase IV clinical trial in India (which also includes a sub-set population to generate pharmacokinetic/pharmacodynamic (PK/PD) and immunogenicity and submit the protocol to CDSCO before placing the drug on the market) as per existing guidelines in the country.
This came in line with the proposal presented by the firm for import and marketing of the drug with the waiver of Phase III clinical trial in the country along with CMC, pre-clinical, and clinical trial data before the committee.
As per the study, Insulin aspart is a rapid-acting form of insulin used for glycemic control in type 1 and type 2 diabetes mellitus. It is a fast-acting insulin that starts to work about 15 minutes after injection, peaks in about 1 hour, and keeps working for 2 to 4 hours. It is typically prescribed for the treatment of diabetes mellitus to imitate the activity of endogenously produced human insulin.
Insulin is released from the pancreas to promote the uptake of glucose from the blood into internal organs and tissues such as the liver, fat cells, and skeletal muscle. The glucose gets transformed into glycogen or fat for storage, after its absorption in cells. Insulin also prevents hepatic glucose production, promotes protein synthesis, and inhibits lipolysis and proteolysis.
Insulin is an important treatment in the management of Type 1 Diabetes, which is caused by an autoimmune reaction that destroys the beta cells of the pancreas, leading to decreased levels of Insulin in the body, required to manage the circulating blood sugar levels. Thus, Type 1 Diabetes patients depend primarily on exogenous forms of insulin, such as insulin aspart, to lower glucose levels in the blood. It is also used in the treatment of Type 2 Diabetes. It is another form of diabetes mellitus that is a slowly progressing metabolic disorder caused by a combination of genetic and lifestyle factors. High blood sugar levels eventually cause cellular resistance to endogenous insulin, and in the long term, damage to pancreatic islet cells.
At the recent SEC meeting for Endocrinology and Metabolism held on 18th May 2022, the expert panel reviewed the proposal for the import and market of the drug Insulin Aspart Injection along with that the CMC, and pre-clinical and clinical trial data were also evaluated.
The committee noted that the firm has conducted Phase I and Phase III trials with the drug in Germany and USA respectively and based on the results of the trial, the drug has been granted marketing authorization by EMA and Health Canada.
After detailed deliberation, the committee recommended the grant of permission to import and market the drug with the waiver of Phase III clinical trial in the country with the condition that the firm should conduct Phase IV clinical trial in India (which also includes a sub-set population to generate (PK/PD) and immunogenicity and submit the protocol to CDSCO before placing the drug on the market) as per existing guidelines in the country.
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