Mr.Drugs that achieve dramatic weight loss will likely see a new boom, experts said, as the first generic versions hit the market this week at a lower cost than the original drugs.
These injections, dubbed “skinny shots” by the media, can help people lose more than 10% of their body weight and have become extremely popular in recent years, with celebrities touting their effects.
They include Wegovy and Saxenda, which are approved for weight loss, and Ozempic and Victoza, which are approved for type 2 diabetes but are often prescribed “off-label” as a weight loss aid. All four mimic a gut hormone called GLP-1 and are produced by Danish pharmaceutical company Novo Nordisk.
It announced on Tuesday that it would invest more than $4 billion (£3.2 billion) in US factories making the injectable drugs to try to meet booming demand.
Although such treatments are available to some NHS patients, private access is expensive and recent shortages have made them difficult to obtain. But change is afoot.
The patents for Victoza and Saxenda have expired, according to Novo Nordisk. As a result, other drugmakers are working on generic versions. Israeli company Teva Pharmaceutical Industries, the world’s largest generic drugmaker, launched a generic version of Victoza in the United States on Monday.
The move comes days after the US regulator, the Food and Drug Administration, provisionally approved the generic version of Victoza from London-based Hikma Pharmaceuticals.
They’re not alone: Others considering launching their own generic products based on liraglutide (the active ingredient in Victoza and Saxenda) include Pfizer, Viatris’ Mylan and Novartis’ Sandoz.
These drugs are cheaper than the originals. According to Teva, the wholesale acquisition cost (WAC) of its new generic will be 13.6% lower than that of Victoza, at $469.60 for the two-pack and $704.40 for the three-pack.
“WAC prices do not take into account price reductions offered to customers and do not reflect our final net price,” a company spokesperson said.
But that’s just the beginning: Ozempic and Wegovy will both lose patent protection in China in 2026, in Europe and Japan in 2031, and in the United States in 2032.
Professor Giles Yeo of the University of Cambridge said generic versions would lead to a new boom in their use, particularly in low-income countries. “Rich people will always want the shiniest new drugs,” he said, adding that new drugs will likely have fewer side effects.
Mark Samuels, chief executive of the British Generic Manufacturers Association (BGMA), described the first wave of generic weight loss drugs as a “potentially transformative opportunity for public health”.
“The current market is largely private thanks to patients paying themselves,” he said. “The cost of the patented medicine is often prohibitive for the NHS, so it has been prescribed sparingly by clinicians. However, the emergence of generic competition will likely reduce the price significantly, meaning the NHS can afford to treat more patients. This has a wider benefit for population health, as better access to these medicines will reduce the crippling pressure that obesity-related conditions place on NHS resources.
In the UK, generic competition typically reduces prices paid by the NHS by 80-90% after loss of exclusivity, according to the BGMA.
Dr Simon Cork, of Anglia Ruskin University, said competition in the form of new drugs will also play an important role in future pricing arrangements of those that currently exist. Eli Lilly’s diabetes drug Mounjaro has just been approved for the treatment of obesity in the UK and is developing another weight loss drug, Retatrutide.
“I suspect that competition will reduce the cost of these drugs, especially since the drugs that come to market often show more favorable weight loss than semaglutide,” he said.
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Victoza generated revenue of £245 million for Novo Nordisk in the first three months of this year, down 23% on the previous year, while Saxenda’s first quarter sales were halved, to £188 million. Last year, Victoza had a turnover of £982 million, down 30% on 2022, while Saxenda posted a turnover of £1.2 billion, in drop of 4%.
The Association of the British Pharmaceutical Industry has defended the use of patents as essential to advances in health.
Claire Machin, executive director of UK international policy and competitiveness at the industry body, said drug development was a high-risk process, with the average cost of a drug from its discovery to its launch being estimated at $2.3 billion last year.
“For every 10,000 compounds tested, only one or two will successfully pass all stages of research and development and clinical trials to become approved medicines available to patients,” she said. “A strong intellectual property framework enables the development of cutting-edge medicines and supports future innovation. »
With generic forms of Victoza appearing this month, Yeo said the big turning point will be when semaglutide – the active ingredient in Ozempic and Wegovy – can be made in generic form. “A powerful drug will then be available to the vast majority of the world, which would be incredible,” he said.
Cork said any reduction in costs was welcome, particularly because at present GLP-1 analogues can only be prescribed for two years’ use on the NHS for eligible patients. “This was introduced largely because of the questionable economics of their continued use,” he said.
“A reduction in cost would shift the balance of this cost-effectiveness, potentially paving the way for their longer-term use – particularly when combined with research showing reversal of weight loss after the patient stops weight loss. taking them, and the continued benefit in terms of cardiovascular risk associated with longer-term use.
Dr. Ivan Koychev from the University of Oxford, who studies the application of GLP-1 analogues in dementia patients, said that demand for these drugs currently exceeds supply due to the high prevalence of obesity and type 2 diabetes.
“This is evidenced by members of the public purchasing these medications online or attempting to reconstitute the medications themselves,” he said.
Although it is unclear how widespread the practice is, Internet forums, including Reddit, have numerous examples of people reporting self-injecting such “DIY” preparations.
However, experts have warned that this approach is dangerous, with some people taking unlicensed versions of semaglutide ending up needing emergency hospital care after buying without a prescription from unregulated online sellers.
Yeo said the availability of cheaper generic versions of drugs such as semaglutide could help solve the problem. “Becoming generic will make its supply much more secure, as it would undermine the hidden market for the product,” Yeo said. “We will also have a lot more information about its long-term safety profile, which can only be a good thing.”