Ozempic generics are coming. But will low-income countries benefit?

Weight-loss drugs, which have taken the world by storm, could soon become cheaper and more widely accessible, with the patent for semaglutide — sold under the brand names Wegovy and Ozempic — set to expire in several major markets in early 2026. Semaglutide is part of a group of drugs that have become central in the fight against obesity and metabolic diseases, with one study estimating that their universal availability could reduce global obesity prevalence by 20% and save 28 million lives over a period of five years. But high prices and intellectual property barriers have left the treatment out of reach to most, especially in low- and middle-income countries. That is likely to change next year, with the patent expiry on semaglutide sparking a race to manufacture copycat — and significantly more affordable — versions of the drug in countries such as India and China. “Very steep generic competition is going to happen over this drug, so the prices are going to fall tremendously,” said Leena Menghaney, a public health and intellectual property expert who previously worked with Médecins Sans Frontières’ Access Campaign. But Menghaney also warned that without strict regulations and government policies, the popularity of the drug would likely result in sales being prioritized in the highly profitable private weight-loss market — with access remaining elusive for diabetes patients and those in lower-income countries. “It’s such a lucrative drug that everyone wants to sell it to high-income and upper-middle-income countries first,” she said. The promise of GLP-1 treatments Semaglutide is part of a class of treatments that work by mimicking glucagon-like peptide-1, or GLP-1, a natural hormone that regulates blood sugar levels and binds to receptors in the brain that control appetite. Studies have shown that weekly injections of Wegovy, the version of the drug sold by Novo Nordisk for weight management, results in an average weight loss of 14.9% to 17.4%. Under the brand name Ozempic, the drug is also used as a treatment for type 2 diabetes. Adult obesity rates have more than doubled since 1990, affecting 16% of adults globally, and diabetes rates have more than quadrupled. A higher-than-optimal body mass index can increase the risk of developing type 2 diabetes and cardiovascular diseases, as well as certain types of cancer. It also caused an estimated 3.7 million deaths in 2021, according to the World Health Organization. As well as treating obesity and diabetes, clinical trials have also shown that GLP-1 drugs may have a range of other health benefits, such as reducing the risk of kidney failure and cardiovascular disease. Emerging research also suggests that they could lower addiction to health-harming substances such as alcohol, and significantly reduce the risk of Alzheimer disease-related dementia among patients with type 2 diabetes. That makes them a critical tool in the fight against the growing burden of noncommunicable diseases, or NCDs, which are placing an increasing strain on national health care budgets and are predicted to cost the global economy $47 trillion between 2011 and 2030. But high prices and a supply chain limited by intellectual property rights mean that GLP-1 drugs currently don’t reach many of the people who medically need them. Almost 80% of global diabetes cases are in low- and middle-income countries, but North America accounts for over three-fourths of the market revenue share. In India, home to 1 in 4 of the world’s diabetes patients, a 2.4 milligram dose of Wegovy currently retails at a price of 16,400 rupees ($186.59) — cheaper than in the U.S., but still unaffordable to the majority. Will generics improve access? With analysts estimating that the global market for weight-loss drugs could reach $150 billion in the next five years, pharmaceutical companies in countries such as India and China are racing to register their own copycat versions. The entry of semaglutide generics into the market could slash prices by up to 80%, some industry experts told Devex, as well as significantly increase the available supply. Patent expiry is usually “good news” for improving access in low-and middle-income countries, said Jayasree Iyer, CEO of the Access to Medicine Foundation. But in the case of GLP-1 drugs, “the demand, the financing available, and the interest of the industry is going towards the obesity and weight loss market,” she said. The weight-loss properties of GLP-1 drugs have caused demand to skyrocket, fueled in part by celebrity endorsements of the treatment for cosmetic purposes. In India, many people “are using the drug to lose weight before a wedding, or they’re using it as a lifestyle drug,” said Menghaney. “That is creating a very, very lucrative private market.” With a highly profitable private market driving demand, access to the drug as a diabetes treatment is taking a back seat. Profit-seeking has already prompted companies to divert resources and production away from the diabetes care market, said Iyer. Shortages of insulin, which is produced by the same handful of companies that manufacture GLP-1 drugs, have been reported in the United States and United Kingdom, with patients fearing that insulin production may be deprioritized due to the high demand and profits to be made from GLP-1 drugs. “The focus right now is the money that they’re getting out of the obesity drugs, and not the necessity of people,” said Deeksha Dev, a patient advocate in India for people living with type 1 diabetes. “While we are making record investments to expand our manufacturing, we are also optimising our portfolio by phasing out older insulin products to free up manufacturing capacity for innovative treatments that serve both diabetes and obesity patients,” a spokesperson for Novo Nordisk told Devex. “This will in the longer term, bolster our ability to provide innovation and a stable, consistent supply of medicine to benefit and best serve the greatest number of patients globally.” “We remain committed to working closely with health authorities and the medical community to ultimately ensure all patients have access to the medication they need,” the spokesperson added, pointing out that the company’s Access to Insulin Commitment guarantees “to provide low-priced human insulin in the poorest parts of the world.” But the commitment only guarantees to provide human insulin in vials. In South Africa, Novo Nordisk opted last year not to renew its contract to supply human insulin in pens, citing “current manufacturing capacity limitations” in a statement to The New York Times. Pen devices make it easier to administer the correct dosage and are linked to higher rates of adherence, Dev said, whereas using a vial and needle can be painful and stigmatizing. “You feel the prick going in way more than that of an insulin pen,” she said. “Who would want to puncture themselves and feel that needle going in?” She fears that the growing demand for GLP-1 drugs, which use a similar delivery device, could further restrict access to insulin pens. National procurement Menghaney said that more work needs to be done to address the access gap in low- and middle-income countries. Government reimbursement schemes could help to rebalance the market to ensure access for diabetes patients, she said, with health ministries making treatments available through national NCD programs. GLP-1 drugs were added to WHO’s list of essential medicines in September. The list serves as a guide for countries on fixing public procurement and reimbursement schemes. Government tendering would create economies of scale, said Menghaney, driving down prices and encouraging pharmaceutical companies to register their generics in low-income countries. But most LMICs are unlikely to adopt the guidelines at the national level any time soon, she said. “At this point of time, the drug is quite expensive, so many countries will not immediately put it into the WHO guidelines,” she said. An Indian pharmaceutical executive, who spoke on condition of anonymity citing intense industry competition and market uncertainties, said that generic drug prices would have to drop below $10 to make national procurement cost-effective. But they estimated that generic drugs would likely be priced initially at around $40, due to the high costs of production and regulatory compliance. “I don’t see the economics going in that direction yet,” they said, predicting that the initial market would likely be mostly private retail. Without national reimbursement and procurement policies, however, generics companies may struggle to reinvest in expanded production capacity and the development of new and improved treatments, said Iyer. “It’s all about how big a piece of the pie can you take in order to take that risk,” she said. Many generics companies are relatively small — and competition is high. “They need the long-term contracts. They need a guarantee that someone’s going to buy this stuff.” Diversified and coordinated procurement Even if procurement does happen at the national level, it is important that governments don’t just opt for the cheapest generic available, said Iyer. LMICs should be careful to ensure diversified supply chains where generics coexist with brand-name drugs, she said, as the revenue made by big pharmaceutical companies is what funds donations — often the only source of treatment available for poorer patients. “We want those products to be available for children and young people, and right now they’re heavily reliant on donations,” she said. “In an ideal setting, you want all these systems to coexist, because the need is so great.” Coordinated procurement across multiple countries could also help to improve access, Iyer said, by helping to ensure the volume required by manufacturers and create economies of scale. But it will take specific conditions, and a “lot of time, investment and political will,” before access is likely to be improved for diabetes patients in the poorest countries, she said. “Just because a patent is expiring, doesn’t mean that immediately you’re going to see the kind of change that you want to see,” she said. Meanwhile, the burden of NCDs continues to rise. Ultimately, GLP-1 drugs are not a silver bullet, said Menghaney, with other policies likely to be more cost-effective in the near term. “Governments need to do much more on the food industry,” she said, with policies to regulate marketing and encourage healthy diets and frequent exercise. “It’s just not enough to medically treat obesity; you have to do much more to control and prevent obesity.”