Dr Reddy’s, Sun, Cipla and Biocon are looking to recreate the Ozempic magic in India

Shivali Rajput, 43, excels at her job, earns well and exceeds her career goals year after year. But when it comes to managing their weight, the efforts of Rajputs have come to fruition, year after year. He weighs 102 kg, about 25 kg above the average weight for his age group. He’s at his wits end, but the thought of going under the knife makes him nervous. So last week he was at a diabetic clinic in Delhi and asked if he could be put on weight loss medication.
Hailed as a revolution, weight loss drugs have surged in popularity, and doctors have witnessed 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 take anti-diabetic drugs to reduce their weight significantly, says Dr. Ambrish Mithal, president of endocrinology and diabetes at Max Healthcare. Most patients have tried to lose weight but have failed because of their temporary efforts, says Dr. Anoop Misra, chairman of the Fortis-CDOC Center of Excellence for Diabetes, Metabolic Diseases and Endocrinology. Occasionally, he says, they get patients asking about weight-loss drugs.

Most of them have tried dieting and put the weight back on in no time, he says, adding that only 5 to 10 percent of the patients he’s encountered are committed to losing weight.

Those who can’t keep their weight off are increasingly looking for help, Misra says.

Read also: Obese people should opt for a structured program of diet, exercise and medication

lay down to
Doctors say patients come in with specific inquiries about weight-loss drugs, which have become both the first choice and the last resort for some. I prefer to go for these shortcuts offered by the pharmaceutical industry than for my looks, says Rajput. The drugs Wegovy and Ozempic that have the same ingredient, semaglutide, have been all the rage since entrepreneur Elon Musk tweeted about it. . The success of these drugs sent shares of Danish pharmaceutical giant Novo Nordisk soaring, making it Europe’s most valuable company. Approved by the US Food and Drug Administration, semaglutide medications mimic the body’s hormone glucagon-like peptide 1 (GLP-1). it helps with insulin production and signals the brain to reduce hunger. While Ozempic was approved in 2017 for the treatment of type 2 diabetes, Wegovy was approved in 2021 to treat obesity.

Novo Nordisk launched Rybelsus oral semaglutide, 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 per one-month dose. While Rybelsus helps diabetes patients lose weight, its injectable counterparts such as Ozempic and Wegovy or Eli Lilly’s Mounjaro/Zepbound have shown significantly better results. These injections are not yet available in India and are in various stages of clinical trials and regulatory approval processes.

It’s not just about weight
It’s all over the place, Eli Lillys global CEO David Ricks told ET in an interview a few months ago. Shares of Eli Lilly hit an all-time high, rising as much as 5% to $742 a share on Feb. 6, after the company reported better-than-expected fourth-quarter earnings, thanks to its drug Fast growing GLP-1.

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 Organization (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 good amount of weight equivalent to the result of surgery, but it has also shown promise in the treatment of fatty liver. The first thing your doctor says when you have one of these diseases is to try to lose some weight. The drug does this in a profound way.

And in some cases, we can reverse the disease. So I think it’s a big breakthrough in medicine, not just in obesity, Ricks said. 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 conducting a global phase 3 clinical trial for its oral drug orforglipron in India, which is expected to conclude next year. This is kind of an ideal medicine for a place like India because we have 300 to 400 million people who are obese or overweight, Ricks said.

Regulatory data obtained by ET show that Eli Lilly has initiated clinical trials to determine the safety and efficacy of orforglipron compared with insulin glargine in people with type 2 diabetes and obesity or overweight at increased cardiovascular risk. Late-stage trials of orforglipron have begun at 12 sites in India with a sample size of 120 participants, according to the Indian Clinical Trials Registry. Research studies from phase two clinical trials published by Eli Lilly last year showed that once-daily orforglipron produced weight loss at levels similar to injectable drugs such as Wegovy or Saxenda, both sold by Novo Nordisk.

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

For men, the prevalence was 5.4%, with an increase of 4.9 percentage points. According to the study, 44 million women and 26 million men over the age of 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 effectiveness in weight control and diabetes.

Regulatory data analyzed by ET show that several new drugs in this category are in advanced stage trials. According to the Indian Clinical Trials Registry, many pharmaceutical companies are keen 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. Indian drug maker Dr Reddys Laboratories is gearing up for a semaglutide drug. The company has received approval from CDSCO’s Subject Matter Expert Committee (SEC) to conduct a bioequivalence (BE) study required to establish the safety and efficacy of semaglutide injection in the Indian population.

Last April, Dr. Reddys approached the SEC with a proposal for the manufacture and marketing of a synthetically developed semaglutide injection of 2 mg/1.5 ml (1.34 mg/ml) and 4 mg /3 ml (1.34 mg/ml). The company also requested a waiver of a BE study and a 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 has also joined the race as the patents on some of the blockbuster drugs are about to expire. The drug company has won approval from the UK regulator for the first generic version of liraglutide injection, which loses patent protection in November. Novo Nordisks weight loss drug, sold under the brand name Saxenda, is among the first anti-obesity drugs to lose patent protection.

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

With a sharp increase in demand, there is a massive shortage of injectable products. Ricks said the supply problem will dissipate if orforglipron is successful in its clinical trial. Given the long-term expansion of the manufacture of injectable forms of weight loss drugs, Ricks emphasized the importance of an oral solid drug.

Eli Lilly and Novo Nordisk are in a pitched battle to dominate the global obesity drug market. Meanwhile, India’s anti-obesity drug market rose to $474 million by January 2024, growing at a CAGR of 32% over a five-year period, according to data from the audit agency pharmaceutical Pharmarack.

Although GLP-1 drugs such as Ozempic and Wegovy have gained popularity, there are problems. Doctors endorse the drug but with a rider. For the most part, they are good. They reduce weight and benefit people with heart, kidney and liver problems. However, patients should not start taking the drug on their own. These are not like paracetamol; a prescription is a must, says Dr Anoop Misra