By Andrew Silver

SHANGHAI (Reuters) – As Novo Nordisk and Eli Lilly increase sales of their popular diabetes and weight-loss drugs, cheaper copies of their patented remedies are winning approval from some foreign regulators, posing a threat for prices and market share of pharmaceutical giants.

Since Novo’s blockbuster diabetes treatment Ozempic was approved in the United States in 2017, regulators have given the green light to 22 drugs containing its main ingredient in Bangladesh, Laos, Russia and Paraguay, as well as ‘seven copies of Lilly’s competing drugs in Bangladesh, according to a Reuters study.

Ozempic’s patented semaglutide ingredient is also used in Novo’s popular obesity treatment Wegovy and diabetes tablets Rybelsus, while Lilly’s tirzepatide is used in Mounjaro and Zepbound.

This year, at least seven new products containing semaglutide have been approved for sale in Laos and Russia, according to public lists of authorized drugs, comments from a regulatory official, details of two drugs approved in Paraguay obtained via a Freedom of Information request and information on the websites of two drug manufacturers.

When asked for effectiveness data on authorized analog versions, regulators in Bangladesh, Paraguay and Russia did not respond. Davone Duangdany, director of the drug and medical device control division at Laos’ health ministry, told Reuters the information was confidential.

Regulators in Bangladesh, Laos and Russia did not immediately respond to Reuters requests for comment on the rigor of their systems for drug approval, development, manufacturing and distribution.

“What I can tell you on behalf of the institution is that the highest and most demanding standards were taken into account for the approval (of the two Paraguayan drugs), as we would do for any other product,” said Jorge Lliou, head of Paraguay’s National Agency. Directorate of Health Surveillance, told Reuters in response to a question about the origin of the active ingredient in locally approved drugs.

The growing number of licensed copies could drive down prices of anti-obesity drugs and risk spillovers in important markets such as India, where Novo’s Rybelsus has already been launched, three pharmaceutical experts said.

Anna Kemp-Casey, a medical policy specialist at the University of South Australia, said prices of weight loss drugs Novo and Lilly would initially remain supported as strong demand currently far outstrips supply.

But “longer term, it is likely that all this competition will put downward pressure on prices” of Lilly and Novo in India and other countries, she added.

Both drugmakers are working to increase their manufacturing capacity to meet unprecedented demand. More than a billion people worldwide are considered obese, a condition linked to a variety of significant health complications. BMO Capital Markets estimates that annual sales of weight loss drugs will reach $150 billion by 2033.

The proliferation of copies could ultimately undermine revenues at Lilly and Novo, whose shares have soared due to high demand for new weight-loss tablets and injection pens containing substances that mimic the activity of a hormone that slows digestion and helps people feel fuller for longer.

The Reuters study focused on countries without a Novo patent on semaglutide, which benefit from patent exemptions from World Trade Organization (WTO) rules due to their status. developing economy, or in which, as in Russia, there are local decrees which override these international regulations. regulations.

“The approval of generics by less strict regulatory agencies provides a legal framework for local manufacturers to produce these drugs both for domestic use and for export,” said Enrique Seoane-Vazquez, a pharmaceutical policy specialist. at Chapman University in California.

Ozempic, which was developed to combat diabetes but achieved worldwide popularity thanks to its weight loss side effect, has become a significant revenue driver for Novo, with sales reaching 95.7 billion Danish crowns (13 .5 billion dollars) in 2023. Sales of Lilly’s Mounjaro reached $5.1. billion last year.

Asked about the copies identified by Reuters, Eli Lilly said tirzepatide was a complex macromolecule that required rigorous testing.

“Any biosimilar product approval policy…presents significant patient safety concerns. Regulators should proceed with caution, prioritizing patient safety,” Lilly said in a written statement.

Contacted by Reuters, a Novo spokeswoman declined to comment on potential risks of price competition from copies from Bangladesh, Laos, Russia and Paraguay.

Asked whether Novo was considering filing a patent application in Paraguay, which does not benefit from an exemption because it does not meet WTO criteria, the spokeswoman said the Danish company was not seeking not to obtain patent protection in every country in the world.

Reuters previously reported that two copies of Novo’s weight loss and diabetes drugs, Orsema and Fitaro, had been approved in Bangladesh. Some injector pens were seized at the border of a wealthier country where Ozempic’s patent is protected, the United Kingdom, according to the same report.

Novo’s patent on semaglutide expires in 2031 in Japan and Europe and in 2032 in the United States, but as early as 2026 in China and India, according to the latest annual report from the company and industry experts. Lilly said in its annual report that its patent on tirzepatide would expire in 2036 in the United States, and later in other major economies.

RACE DOWN

Approved copies identified by Reuters analysis tend to be much cheaper than the originals.

In Russia, for example, a month’s supply of Semavic, used for diabetes and containing semaglutide, costs 4,420.20 Russian rubles ($42.76), according to local manufacturer Geropharm. That’s 24% less than the cost of a month’s supply of Ozempic in Russia, Geropharm told Reuters.

In Bangladesh, a packet of Incepta Pharmaceutical’s Orsema costs 350 or 600 Bangladesh takas ($3 or $5), according to the local online drug information directory Medex.

In the United States, however, the monthly supply of Ozempic had a list price of $935.77 in September, while the weekly injection costs about $100 for each 3 ml dose through China’s public hospital network.

Novo has not launched Ozempic, Wegovy and Rybelsus in Bangladesh, a Novo spokesperson told Reuters.

Due to its affordable price, Semavic attracts potential customers from abroad.

“We have noticed increased interest in this drug, not only in Russia, but also from our foreign partners and colleagues, with requests ranging from (a group of former Soviet republics) to Latin America,” he said. Geropharm said in response to Reuters questions about Semavic’s exports abroad. .

Chirantan Chatterjee, an economist at the University of Sussex in Britain, said the growing importance of the obesity problem could also prompt regulators in parts of Asia to ask big pharmaceutical companies to lower prices.

“So the direction of travel is more competition, lower prices, improved choices and an expansion of consumer welfare in this area,” Chatterjee said.

($1 = 7.0952 Danish crowns) (This story has been refiled to correct a typo in the headline)

(Reporting by Andrew Silver; additional reporting by Gleb Stolyarov in Tbilisi, Daniela Desantis in Asuncion, Ruma Paul in Dhaka; editing by Miyoung Kim and Lisa Jucca)