Alok MalikPresident and Business Head – India Formulations, Glenmark Pharmaceuticals Ltd. shares its vision and impact in an exclusive conversation with ETHealthworld’s Rashmi Mabian Kaur biosimilar Of GLP-1 RA Drug Liraglutide “Lirafit” on diabetes care in India. Edited excerpts:

What inspired Glenmark to develop Lirafit? Can you elaborate on the specific market needs or gaps that Glenmark seeks to address with this innovation?

The rapidly increasing prevalence of diabetes in India and the growing need for more affordable treatment options were the primary reasons behind developing Lirafit. In fact, Glenmark has always been at the forefront of making new diabetes treatments more accessible to a larger group of Indian diabetic patients, be it DDP4 inhibitors (zeta-teneligliptin) or SGLT-2 inhibitors (remo-remogliflozin), such When these treatments were out of reach of many Indian patients. While both these introductions were well received healthcare professionals And for patients, over the last 10 years, we have begun to work on making a new class of drugs called GLP-1 RAs more accessible.

GLP-1 RA as a class is one of the most popular diabetes treatment options worldwide today due to its effective HbA1c control, additional cardio metabolic benefits and weight reduction. It is strongly recommended by most global endocrine societies. However, its use in India is low due to limited access due to very high medical cost burden and frequent dropouts.

We here aim to address this market gap by launching a biosimilar of the popular diabetes and obesity management GLP-1 RA drug Liraglutide, which is priced significantly lower than the branded version. Affordability Lirafit is expected to make the drug more accessible to a larger number of patients type 2 diabetes mellitus In India, where the prevalence of diabetes is 11.4 percent.

Lirafit is considered significantly more affordable than existing alternatives, which could potentially transform access for patients. Can you elaborate on how Glenmark managed to achieve this cost-effectiveness? How much will it cost for patients in India?

We started working on this project three years ago where we conducted intensive primary research to understand the preferences of health care professionals and the needs of patients. As a result, we got a clear response that there is a need to make this medicine affordable to increase its utilization. With greater clarity on pricing, we initiated efforts to enhance economies of scale by offering a world-class product at a reasonable price point, that too at less than Rs 100 per day, thereby promoting its use among Indian diabetic patients. found.

A standard dose of 1.2 mg per day at a 70 percent lower cost of therapy was enough to make Lirafit affordable without compromising its effectiveness or quality. Lirafit is expected to have a significant impact on affordability Indian marketWhere the GLP-1 RA market is currently at Rs 337 crore with an annual growth of 83 per cent (as per IQVIA sales data for the 12 month period ending February 2024 (MAT February 2024)).

Can you share some insights into the clinical trials conducted to assess the efficacy of Lirafit in the management of type 2 diabetes and its potential benefits for weight loss? How does LiraFit align with global health care trends, particularly the recent emphasis on weight management medications?

Clinical trials have shown that liraglutide helps improve glycemic control in adult patients with atherosclerotic cardiovascular diseases (ASCVD) and obesity, as well as type-2 diabetes mellitus. Lirafit (biosimilar liraglutide) has undergone significant research and development with comparability to reference liraglutide including preclinical characterization studies, preclinical repeated-dose toxicity studies in Sprague Dawley rats, and Pharmacokinetics evaluation in healthy, adult human subjects.

A Phase III study showed that Lirafit (biosimilar liraglutide) is non-inferior to originator liraglutide for HbA1c reduction and is an effective treatment option for patients with type-2 diabetes mellitus, with no clinical difference in safety. There is no significant difference from. There were also comparable effects on weight loss, blood pressure and heart rate between the two products.

Liraglutide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) that is able to effectively reduce glycemic parameters, promote weight loss, and ensure cardiovascular protection in patients with type 2 diabetes mellitus. The emphasis on weight management medications is due to the growing epidemic of obesity, which is a significant risk factor for type-2 diabetes, heart disease and other health problems. Liraglutide has demonstrated to be effective in inducing and maintaining weight loss in obese type 2 diabetic patients.

The launch of Lirafit is part of a broader trend in the pharmaceutical industry to develop more affordable biosimilar medicines that can help increase access to essential medicines and improve patient outcomes. The affordability of Lirafit is expected to have a significant impact on the Indian market, where the GLP-1 RA market is currently valued at Rs 337 crore with an annual growth of 83 per cent (as per IQVIA™ sales data for 12-12 February 2024). Month period ending (MAT February 2024)).

Given Glenmark’s position in the Indian pharmaceutical market, can you share the strategic approach adopted by the company to launch the drug in the Indian market?

We are a strong player in the oral anti-diabetic segment, and the launch of Lirafit marks our entry not only into the injectable anti-diabetic market but also into the rapidly growing GLP-1 RA landscape. LiraFit is a part of a larger strategy to address the increasing prevalence of diabetes in India. Glenmark’s first entry into GLP-1 RA with Lirafit paves the way for all future launches/collaborations in this therapy area.

Levim Biotech LLP and BIRAC played a key role in the development of liraglutide biosimilars. Levim’s main strength was in process design for liraglutide biosimilar for which it also holds a patent. Levim’s liraglutide has undergone significant research and development with pre-clinical studies in healthy adult human subjects demonstrating comparability to liraglutide. Phase 3 clinical trial data from Levim demonstrated the efficacy of Lirafit in improving glycemic control in adult type 2 diabetic patients, as well as its effects on atherosclerotic cardiovascular diseases (ASCVD) and obesity.

Additionally, the National Biopharma Mission of the Department of Biotechnology implemented by BIRAC supported Phase I and Phase 3 clinical trials of liraglitide biosimilars. The Mission’s financial support and extended technical expertise helped accelerate product development, making it the first biosimilar of liraglutide to receive Market Authorization Approval (MAA) in India. This has resulted in a significant reduction in the cost of diabetes treatment in India.