weight-loss drugs: Dr Reddy’s, Sun, Cipla and Biocon look to recreate Ozempic magic in India

Shivali Rajput, 43, excels in her job, earns well and overshoots her career targets year after year. But when it comes to managing her weight, Rajput’s efforts have come a cropper, year after year. She is 102 kg, about 25 kg above the average weight in her age group. She is at her wit’s end but the thought of going under the knife gives her the jitters. So last week she was at the clinic of a Delhi-based diabetician, asking if she could be put on weight-loss drugs.
Hailed as a revolution, weight-loss drugs have surged in popularity, with doctors witnessing a meteoric rise in demand for them. A medical curiosity just a few years ago, weight-loss drugs are now the preferred route for people like Rajput. “Almost daily, I get patients who want to be on antidiabetes drugs to reduce their weight significantly,” says Dr Ambrish Mithal, chairman endocrinology and diabetes, Max Healthcare. Most patients have tried to lose weight but have failed due to their temporary efforts, says Dr Anoop Misra, chairman, Fortis-CDOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology. Every now and then, he says, they get patients who enquire about weight-loss drugs.

“Most of them have tried dieting and regained weight in no time,” he says, adding that, only 5-10% of patients he has encountered are committed to losing weight.

“Those who fail to reduce their weight are increasingly seeking help,” says Misra.

Also Read: ‘Obese people should opt for a structured programme of diet, exercise & medication’

Lean in
Doctors say patients come with specific queries regarding weight-loss drugs, which have become both the first preference and the last resort for some. “I would rather go for these short cuts that the pharma industry offers than go under the knife for my appearance,” says Rajput.The drugs — Wegovy and Ozempic — which have the same ingredient, semaglutide, are all the rage ever since entrepreneur Elon Musk tweeted about it. The success of these drugs saw the shares of the Danish pharmaceutical giant Novo Nordisk surge, making it Europe’s most valuable company.Approved by the US Food and Drug Administration, semaglutide medications mimic the body’s glucagon-like peptide 1 (GLP-1) hormone to help with insulin production and signal the brain to reduce appetite. While Ozempic was approved in 2017 for treatment of type-2 diabetes, Wegovy was approved in 2021 to treat obesity.

Novo Nordisk launched the oral semaglutide Rybelsus, called a game-changer in the treatment of type-2 diabetes, in India in 2022. It has three strengths (3 mg, 7 mg and 14 mg), and is priced at about `10,000 for a month’s dose. While Rybelsus helps diabetes patients lose weight, its injectable counterparts like Ozempic and Wegovy or Eli Lilly’s Mounjaro/Zepbound have given significantly better results. These injections are not yet available in India and are in varying stages of clinical trials and regulatory approval processes.

It’s not just about weight
“It’s all over the place,” Eli Lilly’s global CEO David Ricks told ET in an interview a few months ago. Eli Lilly stock hit a record high, rising as much as 5% to $742 per share on February 6, after the company reported better-thanexpected fourth-quarter earnings, thanks to its fast-growing GLP-1 drug.

It plans to launch its diabetes and obesity drug, Mounjaro, in India next year. It is seeking regulatory approvals from India’s drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO). The drug contains tirzepatide and is sold as Zepbound in the US.

The good news about Mounjaro is that it not only helps patients lose a fair amount of weight—equivalent to the result of surgical intervention— it has also shown promise in treating fatty liver. “The first thing your doctor says when you have one of these illnesses is, try to lose some weight. The drug does that in a profound way.

And in some cases, we are able to reverse the disease. So I think it’s a major advance in medicine, not just obesity,” said Ricks. The global market for GLP-1 receptor agonists, including Mounjaro, Wegovy and Ozempic, is expected to reach $100 billion by the end of the decade.

Eli Lilly is also undertaking global phase-3 clinical trial for its oral drug orforglipron in India, which is expected to conclude next year. “That is a kind of ideal drug for a place like India because we have over 300-400 million people who are obese or overweight,” Ricks said.

Regulatory data obtained by ET shows Eli Lilly has started clinical trials to determine the safety and efficacy of orforglipron compared with the insulin glargine in people with type-2 diabetes and obesity or overweight with an increased cardiovascular risk. The advanced-stage trials of orforglipron have started at 12 sites in India with a sample size of 120 participants, according to India’s clinical trial registry. Research studies from phase-two clinical trials released by Eli Lilly last year showed orforglipron taken once daily produced weight loss at levels similar to injectable drugs like Wegovy or Saxenda, both sold by Novo Nordisk.

The pandemic in waiting
Studies suggest that India could be facing an obesity epidemic. According to a new global analysis released by The Lancet in March, 12.5 million children (7.3 million boys and 5.2 million girls) in the country, aged between 5 and 19 years, were grossly overweight in 2022, up from 0.4 million in 1990. The report showed more than 3% prevalence among children and teens, an increase of over 3 percentage points from 1990. The female obesity prevalence has also increased sharply to 9.8%, an increase of 8.6 percentage points from 1990.

For men, the prevalence stood at 5.4%, an increase of 4.9 percentage points. According to the study, 44 million women and 26 million men aged above 20 in India were obese. In 1990, there were 2.4 million women and 1.1 million men.

Eli Lilly has also started trials of its drugs tirzepatide (Mounjaro) and retatrutide in India to test their efficacy in weight and diabetes management.

Regulatory data analysed by ET shows that advanced-stage trials are ongoing for several new drugs in this category. According to India’s clinical trial registry, many pharma companies are eager to enter the anti-obesity market.

The Indian touch
The race for new weight-loss drugs is heating up with Indian companies trying to introduce their products. India’s drug maker Dr Reddy’s Laboratories is gearing up for a semaglutide drug. The company has got a go-ahead from the Subject Expert Committee (SEC) under CDSCO to conduct a bioequivalence (BE) study required to establish the safety and efficacy of semaglutide injection on Indian population.

Last April, Dr Reddy’s approached the SEC with a proposal for the manufacturing and marketing of a synthetically developed semaglutide injections of 2mg/1.5ml (1.34mg/ml) and 4mg/3ml (1.34mg/ml). The company also sought a waiver of a BE study and Phase-III clinical trial. However, the SEC recommended the company to conduct a BE study.

Indian drug makers like Sun Pharmaceutical Industries and Cipla are also developing their anti-obesity drugs. Biocon, too, has joined the race as patents for some of the blockbuster medications are set to expire. The pharma company has won approval from the UK regulator for the first generic version of liraglutide injection, which is losing patent protection in November. Novo Nordisk’s weight loss drug, sold under the brand name Saxenda, is among the first anti-obesity medications to lose patent protection.

In India, Novo Nordisk is also conducting trials of semaglutide with insulin icodec and weight-loss compound cagrilintide. The company is also conducting trials of a new pipeline drug, CagriSema, with 600-odd participants.

With a sharp rise in demand, there is a massive shortage of injectable products. Ricks said the supply-side problem will dissipate if orforglipron is successful in its clinical trial. Given the long lead time to expand the manufacturing of injectable forms of weight-loss drugs, Ricks highlighted the significance of an oral solid drug.

Eli Lilly and Novo Nordisk are in a pitched battle to dominate the global antiobesity drugs market. Meanwhile, India’s anti-obesity drugs market swelled to `474 crore in January 2024, growing at a CAGR of 32% over a fiveyear period, according to data from pharma audit agency Pharmarack.

While GLP-1 medications like Ozempic and Wegovy have gained popularity, there are issues. Doctors vouch for the drug but with a rider. “Largely, they are good. They reduce weight and benefit people with heart problems, kidney problems and issues with the liver. However, patients should not start taking the drug on their own. These are not like paracetamol; a doctor’s prescription is a must,” says Dr Anoop Misra