Sunit Maity
Theramyt Novobiologics Pvt. Ltd., India
Title: Development of biosimilar to Exendin-4, a major drug for Type 2 Diabetes
Biography
Biography: Sunit Maity
Abstract
The hallmark of diabetes mellitus is hyperglycaemia resulting from impaired carbohydrate metabolism. Type 2 diabetes has a complex pathophysiology characterised by deficient insulin activity arising from decreased insulin secretion secondary to beta-cell failure, compromised insulin action in peripheral target tissues (insulin resistance), or a combination of the two abnormalities. Type 2 diabetes accounts for approximately 85% to 95% of diabetes cases in developed regions like the European Union. Age and weight are established risk factors for type 2 diabetes. The majority of patients with type 2 diabetes are overweight or obese. Byetta (Exenatide, Exendin-4) contains exenatide which is an incretin mimetic. Endogenous incretins, such as glucagon like peptide 1 (GLP-1), facilitate insulin secretion following their release from the gut into the circulation in response to food intake. Exenatide is licensed for the treatment of type 2 diabetes mellitus in combination with metformin and/or a sulfonylurea, or pioglitazone in patients who have not achieved adequate glycaemic control with these drugs alone or in combination. The increasing expenditures and cost of treatment of Byetta® highlight the absence of lower-cost generic substitutes for this drug usually referred to as biosimilars or follow-on-biologics. Biosimilars or follow-on biologics are protein-based therapeutic products that are near-identical (similar), comparable and equivalent to the branded therapeutic product. As, there is no single biosimilar developed or approved for Byetta®, we have developed the biosimilar of it using microbial route thus lowering the COGS significantly. The cell line development, process and analytical similarity data will be presented.