Glenmark launches biosimilar of anti-diabetic drug, Liraglutide, in India

Glenmark Pharmaceuticals has launched a biosimilar of anti-diabetic drug, Liraglutide, in India. The drug is being marketed under the brand name Lirafit following the approval from the Drug Controller General of India (DCGI). It is priced at around Rs 100 for a standard dose of 1.2 mg (per day).

Liraglutide belongs to the class of glucagon-like peptide 1 receptor agonist (GLP-1 RA) drugs, which increase glucose-dependent insulin secretion and decrease in appropriate glucagon secretion. It has been approved globally for the management of type 2 diabetes mellitus in adult patients in the US and the EU.

Liraglutide has a proven efficacy in improving glycemic control in patients with type 2 diabetes mellitus. Clinical trials on Indian adult patients with type 2 diabetes mellitus over a 24-week period have demonstrated Lirafit to be effective, safe and well-tolerated. The trials also revealed non-inferior efficacy and a safety profile with that of the reference liraglutide. Additional benefits of liraglutide include effectively lowering glycemic parameters, weight reduction, and cardiovascular safety in patients with type 2 diabetes mellitus.

GLP-1 RA (Glucagon-like peptide-1 receptor agonists) are a group of drugs used in the treatment of type 2 diabetes. Several trials have demonstrated that GLP-1 RAs reduce cardiovascular risk in patients with type 2 diabetes mellitus and ASCVD or high cardiovascular risk and have beneficial effects on cardio-renal outcomes beyond their blood glucose-lowering effects in type 2 diabetes mellitus patients. GLP-1 RAs are recommended in the treatment guidelines by the American Diabetes Association as well as the American Association of Clinical Endocrinology (AACE) Consensus Statement & European Society of Cardiology for type 2 diabetes mellitus patients with co-morbidities, like established atherosclerotic cardiovascular disease and obesity. The American Diabetes Association (ADA) also recommends GLP1RAs therapy for weight loss and lesser risk of hypoglycemia in type 2 diabetes mellitus patients. Drugs belonging to this class include liraglutide, semaglutide, and dulaglutide, among others.