Biosimilars are biological substances that are highly similar to biologics but not identical with patented biological molecules. These are manufactured after the patent expiration of original products. Anti-diabetic biosimilars are help to control the blood glucose levels in the diabetic patients. Commonly used anti-diabetic drugs include biguanides, sulfonyl ureas, GLP-1 receptor agonists, DPP-IV inhibitors, thiazolidinediones, and insulin among others. These are cost-effective molecules with similar potency and efficiency compared with reference biologic molecules. Antidiabetics help diabetic people control their blood glucose levels. Biguanides, thiazolidinediones, DPP-IV inhibitors, -glucosidase inhibitors, sulfonylureas, insulin, and GLP-1 receptor agonists like exenatide are examples of antidiabetics. A biosimilar product is a biological product that has been approved by the FDA because it is very similar to an FDA-approved biological product called a reference product. To demonstrate that the biosimilar manufactured gives the same therapeutic benefit to patients as the reference medication, biosimilar manufacturers must generate data from lab testing and clinical testing.
In May 2017, Sanofi received Committee for Medicinal Products for Human Use (CHMP) recommendation for approval of Insulin Lispro Biosimilar