Will Eli Lilly’s blockbuster obesity drug be available in India in 2025?

Global pharma giant Eli Lilly plans to launch its diabetes and obesity treatment, tirzepatide, marketed under the brands Mounjaro and Zepbound, in India by 2025. However, regulatory approvals are still pending as the Indian authorities await data specific to the Indian population.

In August 2024, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) reviewed Eli Lilly’s proposal for importing and marketing a multi-dose prefilled pen version of tirzepatide under the KwikPen presentation. The proposed dosages ranged from 2.5 mg to 15 mg.

Tirzepatide had already received approval in a single-dose prefilled pen format in January 2024, for use as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes, with the stipulation that Eli Lilly conducts a Phase IV clinical trial in India.

For the multi-dose pen, Eli Lilly submitted a bioequivalence (BE) study conducted in the United States. However, the SEC noted that the study comparing a multi-dose pen with a preservative to the single-dose pen without a preservative failed to meet the prespecified criteria for maximum concentration (Cmax) of the drug in the bloodstream. The committee also pointed out that the data lacked insights specific to the Indian population. As a result, the SEC directed Eli Lilly to provide interim efficacy data from the ongoing Phase IV trial in India, as well as global safety and efficacy data on the multi-dose pen for further evaluation. Eli Lilly has not appeared for any subsequent presentations to provide the requested data, according to the government sources.

The company however has indicated that it remains committed to its timeline for the launch. “India continues to be an important market for Lilly, and we are committed to accelerating the process of bringing our innovative products to the country. We aim to launch tirzepatide in India by 2025, after obtaining all necessary regulatory approvals. The burden of diabetes and obesity is rising in India, and we believe there is a great opportunity to serve the needs of Indian patients,” Vineet Gupta, Associate Vice President and Managing Director of Eli Lilly (India), told Business Today.

Gupta also emphasised the importance of viewing obesity as a chronic disease, advocating for comprehensive care, including lifestyle changes, medication, and, where necessary, bariatric surgery. “It is important that obesity is viewed in the same way as other chronic diseases and that people living with obesity are able to access comprehensive care that can prevent and treat obesity, including lifestyle regimens such as diet and exercise, obesity management medications, and bariatric surgery, to improve their health,” he said.

In related developments, the SEC recently recommended granting permission for Eli Lilly’s weight loss drug, Mounjaro (tirzepatide), to be imported and marketed in India. The approval, granted in June 2023, applies to six doses of the drug in single-dose prefilled pens and vials, subject to the condition that Eli Lilly conducts Phase IV clinical trials and fulfils all quality and manufacturing data requirements.

Mounjaro is already approved in the United States, the European Union, and other countries for chronic weight management and as an adjunct to diet and exercise for type 2 diabetes. Eli Lilly is required to submit its Phase IV trial protocol to CDSCO within three months of the drug’s approval for further review.

Mounjaro is regarded as a significant advancement in the treatment of both diabetes and obesity, with Eli Lilly noting that the drug activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) pathways to help regulate blood sugar. GIP and GLP-1 are hormones that help regulate blood sugar.

After eating, they signal the pancreas to release insulin, which lowers blood sugar. GIP stimulates insulin production, while GLP-1 also reduces sugar production in the liver and helps control hunger. Together, they help manage blood sugar levels, especially in people with diabetes.

The company has also announced plans to expand manufacturing capacity to meet global demand, following its FDA approval for Mounjaro in May 2022.

In the fierce race to dominate the weight loss drug market, Eli Lilly announced on last week that Zepbound outperformed Novo Nordisk’s Wegovy (semaglutide) in a recent clinical trial.

“Both semaglutide and tirzepatide represent significant breakthroughs in managing obesity and type 2 diabetes. In key trials, patients using tirzepatide experienced an average weight loss of 15% to 20% of their body weight, compared to approximately 15% with semaglutide. Tirzepatide also demonstrated superior blood glucose control. Despite these distinctions, individual responses can vary significantly,” said Dr Anoop Misra, Chairman of Fortis C-DOC Hospital for Diabetes and Allied Sciences and Director of the National Diabetes Obesity and Cholesterol Foundation (NDOC).

Eli Lilly’s tirzepatide, marketed as Mounjaro , is approved by the U.S. FDA for type 2 diabetes management and is under review in other countries also like Europe and Japan for additional indications, including obesity-related conditions. In the U.S., the list price for a one-month supply is approximately $1,087. The cost may vary based on insurance coverage, pharmacy benefits, or patient assistance programs offered by Eli Lilly. Other countries where Mounjaro is available or undergoing regulatory review might have different pricing influenced by local healthcare systems and reimbursement policies.

As of now, Eli Lilly has not disclosed any pricing details for tirzepatide in India. As per the doctors and industry experts, pricing information is likely to be announced closer to the launch, which is planned for 2025, subject to approval. Doctors in India have stated that the price should be comparable to other weight loss drugs already available in the country, such as semaglutide.

“The current cost of semaglutide in India is approximately Rs 10,000 per month. It is likely that tirzepatide will be priced similarly or higher, although the company can only confirm the exact price,” said Misra.