‘Skinny jabs’: Weight-loss drugs set for new boom as generic versions emerge | pharmaceutical industry

METERExperts have said drugs that enable dramatic weight loss are likely to see a new boom, as the first generic versions hit the market this week at a lower cost than the original drugs.

The injections, called “skinny shots” by the media, can help people lose more than 10% of their body weight and have become very popular in recent years, with celebrities praising their effects.

They include Wegovy and Saxenda, which are licensed for weight loss, and Ozempic and Victoza, which are licensed for type 2 diabetes but are often prescribed “off-label” as a weight loss aid. All four mimic an intestinal hormone called GLP-1 and are produced by the Danish pharmaceutical company Novo Nordisk.

It announced on Tuesday it would invest more than $4bn (£3.2bn) in US plants making injectable drugs to try to meet growing demand.

While these treatments are available to some patients on the NHS, private access is expensive and recent shortages have made them difficult to obtain. But change is underway.

According to Novo Nordisk, the patents on Victoza and Saxenda have expired. As a result, other drug manufacturers are working on generic versions. Israel’s Teva Pharmaceutical Industries, the world’s largest generic drug maker, 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, tentatively approved London-based Hikma Pharmaceuticals’ generic version of Victoza.

Israel’s Teva Pharmaceutical Industries launched a generic version of Victoza in the United States on Monday. Photograph: Dan Balilty/AP

They’re not alone: ​​Others reportedly planning to launch their own generic liraglutide products (the active ingredient in Victoza and Saxenda) include Pfizer, Viatris’ Mylan, and Novartis’ Sandoz.

These medicines are cheaper than the original ones. According to Teva, the wholesale acquisition cost (WAC) of its new generic will be 13.6% lower than that of Victoza: $469.60 for a two-pack and $704.40 for a three-pack.

“WAC’s pricing does not take into account price discounts offered to customers and does not reflect our final net price,” a company spokesperson said.

But this is just the beginning, as Ozempic and Wegovy will lose their 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 will lead to a further rise in their use, particularly in low-income countries. “The rich will always want newer, shinier drugs,” he said, adding that newer 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 through self-pay patients,” he said. “The cost of patented medicine is often prohibitive for the NHS, so doctors prescribe it sparingly. However, the emergence of generic competition is likely to reduce the price significantly, and this means the NHS can afford to treat more patients. “This has a wider population health benefit as greater access to these medicines will reduce the crippling pressure that obesity-related conditions have on NHS resources.”

In the UK, generic competition typically reduces prices paid by the NHS by 80% to 90% after loss of exclusivity, according to the BGMA.

Dr Simon Cork, of Anglia Ruskin University, said competition in the form of new medicines will also play an important role in any future pricing arrangements of those that exist now. Eli Lilly’s diabetes drug Mounjaro was just approved for obesity in the UK and it is developing another weight-loss drug, Retatrutide.

“I suspect that competition will drive down the cost of these drugs, particularly because the drugs that come to market often show more favorable weight loss than semaglutide,” he said.

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Products like Mounjaro, a diabetes drug from Eli Lilly, will help increase competition in the weight loss market. Photograph: George Frey/Reuters

Victoza generated £245m in sales for Novo Nordisk in the first three months of this year, down 23% on the previous year, while Saxenda’s first-quarter sales halved to £188m. Last year, Victoza made £982m in sales, down 30% from 2022, while Saxenda posted revenue of £1.2bn, down 4%.

The British Pharmaceutical Industry Association has defended the use of patents as vital to advances in health.

Claire Machin, executive director of international policy and UK competitiveness at the industry body, said developing drugs was a high-risk process, and the average cost of taking a drug from discovery to launch was $2.3 billion a year. 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 licensed medicines available to patients,” he said. “A strong intellectual property framework enables the development of cutting-edge medicines and underpins future innovation.”

While generic forms of Victoza are appearing this month, Yeo said the big turning point will be when semaglutide, the active ingredient in Ozempic and Wegovy, can be made as a generic. “Then a powerful drug will be available to the vast majority of the world, which would be surprising,” he said.

Cork said any cost reduction was welcome, especially as GLP-1 analogues can currently only be prescribed for use for two years on the NHS to eligible patients. “This was introduced largely due to the questionable cost-effectiveness of its continued use,” she said.

“A reduction in cost would shift the balance of this cost-effectiveness, potentially paving the way for their long-term use, especially when combined with research showing reversal of weight loss after the patient stops taking them, and the continued benefit in cardiovascular risk associated with long-term use.

The availability of generic forms of semaglutide, the active ingredient in Ozempic and Wegovy, would be a game-changer in the weight loss industry. Photograph: Ida Marie Odgaard/EPA

Dr. Ivan Koychev of the University of Oxford, who is researching the application of GLP-1 analogues in patients with dementia, said that demand for such drugs currently exceeds supply as a result of the high prevalence of obesity and type 2 diabetes.

“This is evidenced by the public either obtaining these medications online or attempting to reconstitute them themselves,” he said.

While it is unclear how widespread the practice is, Internet forums, including Reddit, have numerous examples of people reporting that they have been injecting themselves with these types of “DIY” preparations.

However, experts have warned that the approach is dangerous, as some people taking unlicensed versions of semaglutide end up needing emergency hospital care after purchasing it from unregulated, non-prescription online sellers.

Yeo said the availability of cheaper generic versions of drugs such as semaglutide could help address the problem. “Going generic will make your supply much safer, because that 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.”

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