Glenmark is the first to launch a Biosimilar of the Popular Anti-Diabetic Drug Liraglutide in India

• The anti-diabetic biosimilar has been launched under the brand name Lirafit™ and is indicated for improving glycemic control in adult patients with type 2 diabetes mellitus.
• Clinical trials on Liraglutide have demonstrated several benefits, including effectively lowering glycemic parameters, weight reduction, and cardiovascular safety in patients with type 2 diabetes mellitus.
• Liraglutide belongs to the class of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) that 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.
• Lirafit™ will sharply lower the daily cost of therapy by around 70% to around INR 100; making the drug more accessible to a larger number of patients with type 2 diabetes mellitus in the country.

PUNE: Glenmark Pharmaceuticals Ltd. (Glenmark), a research-led, global pharmaceutical company, has launched a biosimilar of the popular 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 INR 100 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.

Liraglutide belongs to the class of glucagon-like peptide 1 receptor agonist (GLP-1 RA) drugs, which increase glucose-dependent insulin secretion and decrease inappropriate 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.¹⁴

“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 Ltd.

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 24 weeks 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 mellitusand ASCVD or high cardiovascular risk and have beneficial effects on cardio-renal outcomes beyond their blood glucose-lowering effects in type 2 diabetes 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. The American Diabetes Association (ADA) also recommends GLP1RAs therapy for weight loss & lesser risk of hypoglycemia in type 2 diabetes mellitus patients.^6,7 Drugs belonging to this class include liraglutide, semaglutide, and dulaglutide, among others.

Glenmark’s expertise in diabetes management

Glenmark 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™), a novel SGLT-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 months ending August 2023 (MAT August 2023), the market for GLP-1 RA in India is estimated to be INR 259 crores, with an annual growth of 108% against the corresponding period last year (MAT August 2022).