Battle shifts to new class of drugs in diabetes treatment in India

A mega shakeup in India’s Rs 17,400 crore diabetes drug market is on the cards with pharma majors lining up a slew of launches in a new category of medications utilised in the treatment of type 2 diabetes and obesity.
 

Glucagon-like peptide receptor agonist (GLP-1RA) works by activating GLP-1 receptors in the pancreas, which leads to enhanced insulin release and reduced glucagon release responses. 
 

Clinical trials of these drugs have shown to lower glycemic parameters and promote weight loss.
 

Umag Vohra, managing director and global chief executive officer of Cipla, terms GLP-1RA as ‘transformational’, similar to what Statins did in the treatment of cholesterol.
 

“India has 100 million diabetes patients, and many more are undiagnosed. Even if 20-25 per cent start administering GLP-1RA, it would be a significant opportunity,” Vohra said.
 

 Cipla on Thursday said it is working on two drugs in this class —semaglutide and liraglutide — which will be launched in India when the patents expire. 
 

Dr Reddy’s Laboratories (DRL) is conducting a bioequivalence study for semaglutide, and any launch plan will be in keeping with the patent expiry.
 

Glenmark, meanwhile, has already launched a biosimilar version of liraglutide, which is priced at 70 per cent lower than the innovator brand.
 

The semaglutide patent is expected to expire in early 2026.
 

Liraglutide’s (Victoza) patent protection has already expired in 2023, and several global players are now planning to launch 

copycat versions this year.
 

Innovator Novo Nordisk’s semaglutide (Ozempic and Rybelsus) and liraglutide (Victoza) are available in India around Rs 10,000 for a monthly course (semaglutide), and Rs 5,324 for a monthly course (Liraglutide), respectively, depending on the strength the doctor prescribes.

Vohra added that Cipla would try and launch the biosimilar versions of these drugs in the US as well. But it may not happen during the first wave of biosimilar launches in that country, he clarified.
 

Cipla has begun relevant trials (including bridging trials) for both semaglutide and liraglutide. The company did not comment on when they would bring these drugs to India. It would happen after patents expire.
 

Glenmark Pharmaceuticals launched a biosimilar version of liraglutide earlier this month, after getting the nod from the Drugs Controller General of India (DCGI).
 

The company would sell it under brand name Lirafit at a price it claimed would be 70 per cent less than the innovator drug Victoza from Novo Nordisk.
 

DRL received the DCGI nod to carry out a bioequivalence study of semaglutide in October last year. 
 

DRL also sought a waiver for a phase-III clinical trial.
 

A bioequivalence study essentially establishes that two versions of the same drug get absorbed similarly in the body.
 

Sun Pharmaceutical Industries has a GLP-1RA novel candidate named GL0034 under development.
 

Sometime in July 2023, the company announced results from two phase 1 studies that evaluated the tolerability and safety of GL0034 in non-obese and obese adults without diabetes. 
 

Sun Pharma has not disclosed whether it aims to bring this investigational drug to India.
 

Declining to give guidance on future launches, Sun Pharma’s Managing Director, Dilip Shanghvi, in the second quarter analyst call, said: “At a theoretical level, I think both semaglutide and liraglutide are good products, not easy to register. And what you call, we don't expect too many people to get approval because of the complexity. But it will be a good product whoever can get it approved.”
 

Danish drug company Novo Nordisk's Victoza is Glenmark’s competitor in the Indian market.
 

Victoza (3ml rDNA liraglutide) comes in three doses: 0.6 mg, 1.2 mg, and 1.8 mg, which would last for 30 days, 15 days, and 10 days respectively, when administered through a pen of 6mg/ml strength (similar to Lirafit).
 

According to online pharmacy websites, Victoza costs Rs 5,324 per pen. For a 1.2 mg dose, it would cost over Rs 10,000 a month because the pen would typically last 15 days. 
 

Glenmark has priced Lirafit at approximately Rs 100 for a standard daily dose of 1.2 mg, or Rs 3,000 for a monthly course.
 

According to IQVIA, Victoza had a market size of Rs 27 crore as of November 2023. The market for GLP-1 RA in India is estimated to be Rs 259 crore, according to IQVIA sales data. 
 

“We are the diabetes capital of the world. Around 11.5 per cent of the population are suffering from diabetes and it is growing because of our lifestyles and genetic factors. GLP-1 analogs are being used worldwide. In India, the market could not pick up because of the cost of treatment and accessibility. This class of drugs have an impact on diabetes management and cardiovascular events,” President and Head of India Formulations Business at Glenmark Pharmaceuticals, Alok Malik, told Business Standard.
 

In 2022, the market size of GLP-1RA was evaluated to be around $22.4 billion globally. It is anticipated to exhibit sustainable growth at a CAGR of around 9.6 per cent till 2032.