- New off-patent versions have the potential to significantly widen patient availability, whether through the NHS or private prescription.
- Generic versions could provide much-needed capacity to meet growing demand and alleviate shortages.
The first wave of genericised weight loss treatments will provide greater choice and better availability for physicians, in managing patients’ weight loss needs, according to the British Generic Manufacturers Association (BGMA), the trade body for off-patent medicines.
Novo Nordisk markets Liraglutide under the brand names Victoza and Saxenda, indicated for the treatment of type 2 diabetes and weight loss respectively. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist used primarily to treat type 2 diabetes and obesity. Liraglutide’s patent protection is no longer in force, marking the first time generic versions of these diabetes and weight loss treatments can be available in the UK.
At least four companies are expected to have UK marketing authorisations with indications to cover type 2 diabetes and obesity. It is unclear how many will launch immediately.
However, 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. In the case of these weight loss treatments, while the demand will undoubtedly increase after the patent expiry, it is not clear how much unmet demand exists. Unlike most medicines prescribed on the NHS, there is also a significant market in private prescriptions, whether available in high street or online pharmacies.
Another factor is the availability of alternative patented branded products such as Mounjaro and Wegovy (also known as Ozempic, prescribed for type 2 diabetes), which 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. Mounjaro and Wegovy will lose patent protection in 2032 and 2028, respectively.
However, the competing off-patent versions will bring greater capacity and choice, allowing the NHS to start treating increased numbers of patients for weight loss and type 2 diabetes with the broader long-term benefits that can deliver. Indeed, there have been shortages of Saxenda and Victoza for a year prior to patent expiry, and so generic versions will provide more market capacity and resilience. Patients wanting private prescriptions will also get more choices.
Genericisation and greater availability therefore provide a very significant cost benefit, with for example, the Tony Blair Institute estimating that obesity costs society £98bn a year.
Mark Samuels, Chief Executive of the British Generic Manufacturers Association (BGMA), said: “The genericisation of the first wave of weight loss medicines is 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. The hope is that weight loss medicines can help more Britons to live healthier in the long term, increasing productivity and saving the billions that obesity costs the NHS annually. The estimated annual NHS spend on obesity-related diseases is £6.5 billion.
“However, the BGMA also advocates that for these treatments to be successful, weight loss medicines continue to be prescription-based and not available as an over-the-counter product. This should be the case whether they are obtained via the NHS or privately. It is essential for those selling the medicines to ensure that patients have regular GP consultations and can report any concerns.”
Mark Samuels added, “These medicines are not a magic bullet and must be used alongside the required policy changes, such as addressing the obesogenic environment. Moreover, 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.”
ENDS
For further information about the BGMA please contact Jeremy Durrant on 07792918648 or email Jeremy.durrant@britishgenerics.co.uk
“Despite being intrinsic to the health and well-being of our nation, the generic and biosimilar medicine sector has been largely ignored from a policy perspective. The EU-UK Trade and Cooperation Agreement has hurt the UK’s medicines supply resilience, adding regulatory and logistical complexity to an industry that relies on simplicity to survive. Our sector supplies the NHS with high volumes of medicines but with razor-thin margins. Throw in a volatile Government pricing system over the past five years alongside a doubling of domestic regulatory delays, then the UK is becoming an increasingly unattractive market for international companies.”
Mark Samuels, chief executive of the BGMA
“The success of the UK’s off-patent market has long been envied, but the huge progress achieved is being undermined by a policy vacuum that prioritises new medicines only. New treatments are incredibly important, but we cannot ignore the established medicines, which represent the vast majority of prescription products taken every day by patients. We must act to prevent the possibility of the UK becoming a backwater market regarding medicines supply and the consequences that means for us all in accessing vital treatments.”
Mark Samuels, chief executive of the BGMA