At least four companies are expected to have UK marketing authorisations for generic weight loss medicines
With Novo Nordisk's patent protection for liraglutide now expired, the UK is set to welcome the first wave of generic weight loss medicines.
The British Generic Manufacturers Association (BGMA), the trade body for off-patent medicines, believes these generic versions could “provide could provide much-needed capacity to meet growing demand and alleviate shortages.”
Liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is primarily used to treat type 2 diabetes and obesity. Novo Nordisk markets liraglutide under the brand names Victoza (for type 2 diabetes and Saxenda (for weight loss).
In a statement released on 20 November 2024, the BGMA confirmed that “liraglutide’s patent protection was no longer in force, marking the first time generic versions of diabetes and weight loss treatments can be available in the UK.”
The BGMA anticipates that at least four companies will obtain UK marketing authorisations for generics targeting type 2 diabetes and obesity. However, it remains uncertain how many will launch immediately.
In October, leading Indian generic drug manufacturer Biocon announced that it had secured UK authorisation to launch a generic version of Saxenda, with sales expected to commence in November.
Biocon CEO Siddharth Mittal projected annual UK sales of the drug to reach £18 million.
Rising demand
BGMA noted that the availability of genericised weight loss treatments could provide “greater choice and better availability for physicians in managing patients’ weight loss needs.”
Prior to patent expiry, there have been shortages of Saxenda and Victoza for a year in the UK.
The BGMA suggested that introducing generic versions would increase “market capacity and resilience,” and “patients wanting private prescriptions will also get more choices.”
While the body is confident that the demand for generic weight-loss medicines will rise, it is not clear how much unmet demand exists.
“Demand is expected to be far harder to predict than for typical generic or biosimilar markets, which generally unlock a steady rise in demand as the price declines, enabling the NHS to widen access following the loss of exclusivity,” it said, explaining that “there is also a significant market in private prescriptions.”
The BGMA noted that the availability of alternative patented branded products such as Mounjaro (tirzepatide; Eli Lilly) and Wegovy (semaglutide; Novo Nordisk). These alternatives require once-a-week jabs compared to daily injections with liraglutide.
“Some patients may prefer the once-weekly injections, while others may be agnostic if generic Liraglutide’s price point is more affordable,” it said.
Patents for Mounjaro and Wegovy (also known as Ozempic, prescribed for type 2 diabetes) will expire in 2032 and 2028, respectively.
Cost-saving potential for the NHS
Mark Samuels, chief executive of the BGMA, described the genericisation of the first wave of weight loss medicines as “a significant development for the NHS and societal healthcare more broadly in the UK.”
“These products can potentially deliver essential public health benefits and access to medicines, possible NHS cost savings, and broader knock-on benefits – provided policymakers see these medicines in the context of other factors, such as tackling the issues regarding unhealthy foods and sedentary lifestyles,” he said.
Samuels added that weight-loss medicines could help more Britons to live healthier in the long term, increasing productivity and saving the billions that obesity costs the NHS annually.
He noted that obesity-related diseases cost the health service an estimated £6.5 billion a year.
Prescription-only access
The BGMA strongly advocates that weight-loss treatments remain prescription-based and unavailable over the counter.
“This should be the case whether they are obtained via the NHS or privately,” Samuels emphasized, urging those selling the medicines to ensure patients have regular GP consultations and can report any concerns.
“These medicines are not a magic bullet,” Samuels cautioned, adding that they “must be used alongside the required policy changes, such as addressing the obesogenic environment.”
“People living with Type 2 diabetes or obesity need appropriate support, and healthcare providers have a responsibility to ensure adequate ongoing care is in place, as befits any other prescription medicine on which a patient is maintained for some time,” he added.
