Development of bio-similar to exendin-4, a major drug for type 2 diabetes

4^th International Conference and Exhibition on Biologics & Biosimilars

October 26-28, 2015 Baltimore, USA

Sunit Maity

Theramyt Biologics Private Limited, India

Posters-Accepted Abstracts: J Bioanal Biomed

Abstract :

The hallmark of diabetes mellitus is hyperglycemia resulting from impaired carbohydrate metabolism. Type 2 diabetes has a complex patho-physiology characterized by deficient insulin activity arising from decreased insulin secretion secondary to betacell 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 glycemic 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 followon- 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 bio-similar developed or approved for Byetta�®, we have developed the bio-similar of it using microbial route thus lowering the COGS significantly. The cell line development, process and analytical similarity data will be presented.

Biography :

Email: sunit_maity@theramyt.com