Prices for Indian consumers are expected to come down significantly from the current Rs 17,000-Rs 26,000 monthly.

Kindly note the image has been posted only for representational purposes. Photograph: Kind courtesy Vidmir Raic/Pixabay.com

As global demand for next-generation therapies on diabetes and weight loss surges, Indian pharmaceutical companies are gearing up to roll out generic versions of semaglutide once its patent expires around March next year.

Semaglutide is a GLP-1 (glucagon-like peptide 1) receptor agonist that is used as an active pharmaceutical ingredient in medications for obesity management and Type-II diabetes.

The generic launches will be significant because the prices for the Indian consumer are expected to come down significantly from the current Rs 17,000-Rs 26,000 (monthly), expanding patient coverage.

Dr Reddy’s Laboratories (DRL), Cipla, Sun Pharma, and Mankind Pharma, among others, are laying the groundwork for Day 1 launches, ramping up peptide manufacturing, forging device partnerships, and aligning regulatory strategies to capture a share of the fast-growing GLP-1 market, estimated to cross $150 billion globally by the end of the decade.

DRL is planning a rollout of semaglutide across 87 countries next year, with Day 1 launches in India and Brazil as patents expire.

“The semaglutide launch is important to us,” said CEO Erez Israeli, adding that it would be priced below Danish drugmaker Novo Nordisk’s offer of around Rs 17,000 per month.

The company is developing 26 peptide-based GLP-1 therapies for phased launches over the next decade, backed by capex of Rs 2,700 crore in FY26, to scale up the production of peptides and biosimilars.

Cipla is targeting first-wave launches through a mix of in-house and partner filings.

‘We see GLP-1 as one of the biggest therapy opportunities in the last five years,’ said Umang Vohra, managing director and Global CEO at the post-earnings call.

The firm is building parts of its GLP-1 supply chain internally while leveraging partnerships to ensure scalability.

Cipla is also crafting an affordable strategy for India’s price-sensitive market, betting that post-patent price erosion will be offset by volume growth.

Mankind Pharma aims to launch both oral and injectable semaglutide generics, alongside developing MKP10241, a novel oral obesity drug now in Phase-II trials in Australia.

Sun Pharma is taking ahead its investigational GLP-1 molecule Utreglutide, targeted for launch in four to five years.

It has secured Phase-III approval for semaglutide trials in India, even as it reports a negligible impact of GLP-1 drugs on its existing diabetes portfolio.

The race for a piece of India’s Rs 628 crore anti-obesity market, however, comes at a time when the Indian courts and the drug regulator are looking to monitor the unregulated use of weight-loss drugs.

According to sources, the Central Drugs Standard Control Organisation (CDSCO) has initiated work to form a panel after the Delhi high court in July asked it to consult experts and stakeholders to look into concerns arising out of approval for drug combinations being sold in the market for weight loss.

The directive came in response to a public interest petition filed by fitness entrepreneur Jitendra Chouksey, who had raised concerns about the marketing approval of drugs such as semaglutide, tirzepatide, and liraglutide for weight management, despite the limited safety data and an absence of India-specific clinical trials.

While disposing of the petition, the court asked the drug regulator to respond to the petitioner within three months.

Currently, India has two available forms of semaglutide — Rybelsus (oral) and Wegovy (injectable) — both manufactured and marketed by Novo Nordisk.

While the former is approved to treat Type-II diabetes, Wegovy was launched for weight management in June.

The other obesity-management drug available in India is America-based Eli Lilly’s Mounjaro (tirzepetide).

Experts say the semaglutide opportunity is fuelling India’s peptide manufacturing.

“Formulation is no longer enough. Companies need full-stack execution,” said Nirali Shah, pharma analyst, Ashika group, highlighting early moves by DRL, Cipla and Sun Pharma to secure pen delivery partnerships.

On the other hand, contract development and manufacturing organisations such as Anthem Biosciences and Syngene are strategically positioning themselves to capture a bigger share of the peptide market while device makers are boosting pen production.

According to Nilaya Varma, CEO of Primus Partners, India’s peptide CDMO market, $80 million, is growing at a compound rate of 14 per cent and could play a role in supplying GLP-1 drugs globally.

Lean move

• DRL, Cipla, Mankind, Sun Pharma preparing to launch generic semaglutide
• Generics to significantly cut costs of weight-loss therapies
• India now has only 2 forms of semaglutide — Rybelsus (oral) and Wegovy (injectable), both manufactured by Novo Nordisk
• Semaglutide opportunity fuelling India’s peptide manufacturing ecosystem
• CDSCO panel to begin consulting experts over side effects, unregulated sales

Feature Presentation: Ashish Narsale/Rediff