Earlier this month, Novo Nordisk Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound were removed from the FDA shortage list. Although these GLP-1 diabetes and weight loss drugs are no longer in short supply in the United States, there are many countries in the world that do not have access to them. Aside from ongoing manufacturing and supply chain challenges, Novo and Lilly’s GLP-1 drugs are primarily available in the United States, Canada and parts of Europe.
In contrast, Sanofi appears to be doing great in globalizing its GLP-1 diabetes drug Soliqua. So far, the company has successfully obtained approval for Soliqua in 84 countries, and a company spokesperson said BioSpace that Sanofi has made it possible for those who need it to have access to this medicine.
Unlike Novo and Lilly’s products, Soliqua is not effective in weight loss. However, experts say the company’s broad distribution network in the GLP-1 market could give it an advantage over other companies if Sanofi decides to re-enter the market for GLP-1 drugs for obesity treatment.
“Sanofi has a sophisticated global distribution system,” said Paul Hickey, CEO of Reshape Life Sciences, which develops medical devices to treat obesity. “It is possible that Sanofi’s supply chain network could provide a significant advantage if the company were to enter the obesity market.”
Current coverage of GLP-1 from Novo and Lilly
In addition to the US and European markets, Lilly and Novo are apparently pushing for sales of their GLP-1 drugs in China. Novo’s Wegovy was approved in the country in June, closely followed by Lilly’s Zepbound. Novo CEO Lars Fruergaard Jørgensen said Reuters Earlier this year, the company announced it would focus on markets where it saw “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 the world, including North America, where figures fell 71% in the first half of this year compared to the same period last year.
However, there are many opportunities for GLP-1 drugs worldwide. Wegovy is only available in eight countries in Europe, the Middle East and Africa, but sales of Novo’s obesity products in these regions increased by 67% this year compared to an increase of 35% in North America.
As for Lilly, its Chairman and CEO David A. Ricks told Business today Earlier this year, he said the “overall goal is to distribute our medicines worldwide,” but said the political landscape in small markets like India is too difficult for multinationals.
While obesity was once considered a disease of industrialized countries, it is gradually increasing in developing countries. A study by the Food and Agriculture Organization of the United Nations, for example, showed that Obesity rate in rural Egypt from 15% in 1992 to 44% in 2015, surpassed the USA this year. In 2022, India ranked third on the list of countries with the most Adults with obesity.
“We are advocating for these drugs to be available in all countries because they are so effective and can help so many patients,” said Carel Le Roux, director of the Metabolic Medicine Group at University College Dublin and a doctor at Lindus Health, a clinical research organization. He pointed out that Wegovy and Zepbound are not available in many European Union countries.
Jørgensen said Reuters Last year, Novo announced plans to launch its drugs in many countries, but the launches will be dribbling and drab, and experts say the shortage problem is likely to persist.
While Novo and Lilly are withdrawing from the Drug shortage at the FDA Hickey said that may not solve the supply problem when the company registers this month. Both companies are actively investing in production, but “it takes a while to get another plant up and running in the U.S. or any other country,” he said.
Costanza Alciati, pharmaceutical analyst at GlobalData, said the drugs would not reach new markets until companies overcome their shortage problems.
Many companies, including Novo and Lilly, want to solve the production and supply problems by developing oral options“This is very exciting,” said Le Roux.
“If you make a product that is a peptide and needs to be injected, that’s a big manufacturing process. Whereas if you make a small molecule that could be used as a tablet, that scales up much faster,” he explained. “If someone has a scalable tablet, that’s a good thing because we can help more patients.” But right now, the only GLP-1 options are injections.
Hickey told BioSpace that the global shortage of GLP-1 has prompted some countries like India to develop alternatives to Wegovy and Zepbound by using locally manufactured products. This practice could become a general trend in the coming years, he added.
Sanofi’s GLP-1 strategy
Sanofi’s first attempt at a GLP-1 drug was in obesity. The company launched Acomplia in 2006 after receiving approval from the EMA, but the regulatory authority soon withdrew it due to an increasing number of mental disorders associated with the drugSanofi persisted and developed Soliqua, a GLP-1 agonist for the treatment of type 2 diabetes in adults.
A Sanofi spokesman said BioSpace In an emailed statement, the company said it had “made the strategic decision to focus on Soliqua, a combination therapy of GLP-1 and basal insulin, to help people manage their diabetes.” The spokesperson added that Soliqua has now become one of the cornerstone therapies in its diabetes portfolio and represents an important growth factor for the company.
“When you bring a product like this to market, you have to go as fast as possible, but also as slowly as necessary,” said Hickey, explaining that GLP-1 drugs have been in the spotlight since the introduction of Number of safety concernsManufacturers take particular care during development to avoid bringing drugs with irreversible side effects onto the market.
Sanofi has no GLP-1 drug for obesity in the pipeline. The company said BioSpace that the company’s research focus is currently on immunological therapies.
