Glenmark Pharmaceuticals, a research-led, global pharmaceutical company, has launched a biosimilar of the popular10,11 anti-diabetic drug, Liraglutide, for the first time in India. The drug is being marketed under the brand name Lirafit following the approval from the Drug Controller General of India (DCGI). Priced at around Rs100 for a standard dose of 1.2 mg (per day), this will lower the cost of therapy by approximately 70%, and will be available only under prescription, the company said.
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.12,13 It has been approved globally for the management of type 2 diabetes mellitus in adult patients in the United States and the European Union.
“Glenmark is proud to introduce Lirafit, a novel and affordable biosimilar of the drug liraglutide, for the first time in India. Clinical trials have shown that it helps improve glycemic control in adult type 2 diabetes mellitus patients along with atherosclerotic cardiovascular diseases (ASCVD) and obesity. Liraglutide has also proven to have a positive impact on cardiac and renal safety outcomes among patients in clinical trials, making it an effective choice of treatment for patients with type 2 diabetes mellitus. With this launch, we have now ventured into the injectable anti-diabetic market taking another significant stride in the diabetes therapy space,” remarked Alok Malik, president and Business Head – India Formulations, Glenmark Pharmaceuticals.
Liraglutide and its role in the treatment of type 2 diabetes
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 class of drugs and their mechanism of action
GLP-1 RA (Glucagon-like peptide-1 receptor agonists) are a group of drugs used in the treatment of type 2 diabetes. GLP-1 RAs are very effective in lowering blood sugar levels. 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. Their mechanism of action involves the release of insulin, in the presence of elevated glucose concentrations, thus decreasing glucagon secretion. 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.6,7,8,9. The American Diabetes Association (ADA) also recommends GLP1RAs therapy for weight loss & lesser risk of hypoglycemia in type 2 diabetes mellitus patients. Drugs belonging to this class include liraglutide, semaglutide, and dulaglutide, among others.
Glenmark’s expertise in diabetes management
Glenmark says it has a strong legacy of bringing in new, effective, and affordable treatment options for diabetic patients, especially for those suffering from uncontrolled Type 2 diabetes. In 2015, Glenmark was the first to launch the DPP4 inhibitor, Teneligliptin (Zita Plus and Ziten), followed by a FDC of Teneligliptin + Metformin (Zita-Met Plus and Ziten-M).
Glenmark later introduced Remogliflozin (Remo and Remozen), aSGLT-2 inhibitor in 2019; and subsequently, its combinations (Remo-V, Remozen-V, Remo MV, and Remozen MV). Glenmark followed that up with the launch of Sitagliptin (Sitazit) and its FDCs in 2022. Then came Lobeglitazone (LOBG) and additional FDCs of Teneligliptin, including its combinations with Pioglitazone (Zita Pio), Pioglitazone + Metformin (Zita-PioMet), Dapagliflozin (Zita-D), and Dapagliflozin + Metformin (Zita DM). Liraglutide (Lirafit), a glucagon-like peptide-1 receptor agonist (GLP-1 RA) is the latest affordable offering from Glenmark, marking its entry into the injectable anti-diabetic market.
Prevalence of diabetes in India
As per the ICMR-INDIAB study conducted between October 2008 and December 2020, the overall weighted prevalence of diabetes was 11.4%. According to IQVIA sales data for the 12–month period ending August 2023 (MAT August 2023), the market for GLP-1 RA in India is estimated to be Rs 259 crore, with an annual growth of 108% against the corresponding period last year (MAT August 2022).
