Experts say Novo Nordisk and Eli Lilly’s GLP-1 drugs are unlikely to reach more countries in the near term, but Sanofi’s diabetes treatment has gained ground globally.
Earlier this month, Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound were removed from the FDA shortage list. But while these GLP-1 drugs for diabetes and weight loss may no longer be in shortage in the U.S., there are many countries around the world that cannot access them. Beyond continued manufacturing and supply chain challenges, Novo and Lilly’s GLP-1 drugs are mainly available in the U.S., Canada and parts of Europe.
In contrast, Sanofi seems to be excelling at globalizing its GLP-1 diabetes medication Soliqua. So far, the company has successfully garnered approval for Soliqua in 84 countries, and a company spokesperson told BioSpace that Sanofi has made it possible for those who rely on this medicine to get access to it.
Unlike Novo and Lilly’s products, Soliqua is not effective in managing weight loss, but experts say its broad distribution network in the GLP-1 market might give it an edge over other companies if Sanofi decides to jump back onto the GLP-1 obesity drug train.
“Sanofi has a sophisticated global distribution system,” said Paul Hickey, CEO of Reshape Life Sciences, which develops medical devices for treating obesity. “It’s possible that Sanofi’s supply chain network could offer a substantial advantage if the company were to venture into the obesity market.”
Current Reach of Novo and Lilly’s GLP-1s
In addition to the U.S. and European markets, Lilly and Novo appear to be pushing for sales of their GLP-1 drugs in China. Novo’s Wegovy was approved in the country in June, followed closely by Lilly’s Zepbound. Novo CEO Lars Fruergaard Jørgensen told Reuters early this year that the company will aim at markets where it had “strong sales” of Saxenda, an older weight loss drug. But the company’s Q2 report shows that sales of Saxenda have declined in many regions of the world, including North America, where the numbers dropped by 71% in the first half of this year compared to the same period last year.
However, there is much opportunity around the world for GLP-1 drugs. Wegovy is only available in eight countries throughout Europe, the Middle East and Africa, but sales of Novo’s obesity products across these regions increased by 67% this year compared to a 35% increase in North America.
As for Lilly, its Chair and CEO David A. Ricks told Business Today early this year that the “overarching goal is to distribute our medicines globally.” He stated, however, that the policy landscape in small markets like India is too challenging for multinationals to navigate.
While obesity was previously thought to be a disease of developed countries, it is gradually growing in prevalence in the developing world. For example, a study conducted by the Food and Agriculture Organization of the United Nations showed that the rate of obesity in rural Egypt went from 15% in 1992 to 44% in 2015, surpassing the U.S. that year. In 2022, India ranked third on the list of countries with the most adults with obesity.
“We’re advocating for all countries to have these medications because they’re so effective and they can help so many patients,” said Carel Le Roux, expert advisor to Lindus Health, a clinical research organization, and director of the Metabolic Medicine Group at University College Dublin. He noted that Wegovy and Zepbound are not available in many countries in the European Union.
Jørgensen told Reuters last year that Novo plans to take its medicines to many countries, but the launches will come in trickles. Experts say the shortage problem is likely to persist.
While Novo and Lilly pulled themselves from the FDA’s drug shortage register this month, Hickey said this might not fix the supply problem. Both companies are actively investing in manufacturing, but “it takes a while to get another plant up and running in [the] U.S. or in another country,” he said.
Costanza Alciati, a pharma analyst at GlobalData, said the drugs will only get to new markets after the companies overcome their shortage issues.
Many companies, including Novo and Lilly, want to overcome manufacturing and supply issues by developing oral options. This is very exciting, Le Roux said.
“If you make a product that is a peptide that needs to go into an injection, that’s a big manufacturing process, whereas if you made a small molecule that could be a tablet, that’s something that could be scaled much faster,” he explained. “If somebody has a tablet that is scalable, that’s a good thing because we can help more patients.” But for now, the only GLP-1 options are injectables.
Hickey told BioSpace that global GLP-1 shortages have driven some countries like India to generate alternatives to Wegovy and Zepbound using locally sourced products. This practice could become a common trend in the coming years, he added.
Sanofi’s GLP-1 Strategy
Sanofi’s first try at a GLP-1 drug was in the obesity indication. The company rolled out Acomplia in 2006 following approval by the EMA, but the regulatory agency soon withdrew its nod due to an increased number of psychological disorders that were associated with the drug. Not relenting, Sanofi went on to develop Soliqua, a GLP-1 agonist for treating type 2 diabetes in adults.
A Sanofi spokesperson told BioSpace in an emailed statement that the company “made the strategic decision of focusing on offering the combination therapy Soliqua consisting of GLP-1 and basal insulin to help people manage their diabetes.” The spokesperson added that Soliqua has since become one of the cornerstone therapies in its diabetes portfolio and represents an important growth asset for the company.
“You need to go as fast as you can but as slow as you should when you commercialize a product of this type,” Hickey said. He explained that since GLP-1 drugs have raised a number of safety concerns, manufacturers are extra careful during development to avoid pushing out medications with irreversible adverse effects.
Sanofi does not have a GLP-1 obesity drug in its pipeline. The company told BioSpace that it is currently focusing its research efforts on immunology therapies.
Correction (Aug. 21): The description of Carel Le Roux’s affiliation has been corrected to note that he is an advisor to Lindus Health. BioSpace regrets the error.
