Key Summary
- The report says that without a decisive action the NHS risks facing a ‘biosimilar void’.
- Biosimilars are expensive to make with development costs averaging more than £200 million.
- The confirmatory phase III trials currently account for roughly half of these costs.
A new research by Medicines UK found that 74 major biologic medicines, including weight‑loss treatment semaglutide, are set to lose exclusivity by 2032, but without a decisive action the NHS risks facing a ‘biosimilar void’, as manufacturers struggle to recoup of cost of bringing a biosimilar to market.
This void would deny the NHS billions of pounds in potential savings and restrict patient access to treatments that could be offered earlier in clinical pathways.
"It would destroy the classic pharmaceutical affordability model that has been accepted over the past thirty years whereby new innovation is paid for the generic and biosimilar entrants bringing down prices when patents expire," the report said.
Medicines UK Chief Executive Mark Samuels said: “The UK has a once‑in‑a‑generation opportunity to secure billions in savings and expand patient access through biosimilars. But that opportunity is not guaranteed.
"Biosimilars are expensive to make, and so we need to make supplying them attractive to create NHS access to the largest number.
"Conversely, as global demand accelerates, likely for the big biologic blockbusters coming off-patent, manufacturers will prioritise the most attractive markets to achieve a return on investment - and unless we act decisively, the UK risks falling to the back of the queue. We must ensure the NHS remains a first‑choice destination for biosimilar launches, not a market that gets left behind."
High costs
The report said that biosimilars are developed and commercialised based on global market opportunity, with development costs now averaging more than £200 million.
The confirmatory phase III trials currently account for roughly half of these costs, and many regulators are moving away from it.
In contrast, a generic medicine may require no more than £5m to develop and bring to market.
The report categorises the 74 biologics into two groups:
- Category 1: High‑value UK targets with annual sales above £37.5m.
- Category 2: Products with limited UK commercial opportunity due to low NHS usage, despite significantly higher sales in the EU and US.
The analysis identified 24 high-value core products poised to lose patent, and found that 23 of them share identical UK and EU patent expiry dates.
In the case of seven products, the UK launches are likely to occur earlier than in the US, and for 10 products, US launches may come first due to different IP strategies.
The report said the major revenue shifts will happen in 2028 and 2031.
In 2028, high‑value entries will be worth approximately £656m, and in 2031 there will be a bigger shift of around £2.23bn.
Overall, these 24 biologics represent £5.1bn based on annual NHS List Price spend, excluding confidential originator discounts, including via patient access schemes, the report said.
Latent demand
The remaining 50 biologics each have annual UK sales below £37.5m, however, it has a bigger potential in the EU and US markets.
In the EU market, 29 of these 50 biologic products exceed £75m in annual sales, with a combined brand value of £7.8bn.
In the US, 34 products exceed £75m, totalling £20.3bn. Hence, prioritising these molecules could unlock significant latent demand.
Discounted biosimilars often trigger clinical pathway reviews, shifting treatments from last‑line to earlier‑line therapy. This can transform niche biologics into high‑volume commercial successes while dramatically reducing NHS costs.
Samuels said, “The Government has done some fantastic work to get the UK positioned as a global launch leader for biosimilars. However, as well as major loss of exclusivity molecules on the horizon, there is a long tail of smaller-value products which currently have no pipeline of competition.
"This matters as they can collectively make a substantial difference to access as well as further savings of hundreds of millions of pounds.
"Due to their lower cost, they also have the potential to become first-line treatments and grow exponentially in terms of patient uptake. This will improve patient treatment outcomes and it will unlock knock-on NHS system benefits where people stay healthier and more active for longer."
Stiff competition
However, the report warns that European nations like France and Germany are actively seeking to increase biosimilar penetration, and even the world's largest pharmaceutical market US is trying to catch up.
In such a situation, the finite biosimilar manufacturing capacity, will increasingly be prioritised to meet US demand, especially with regard to the biologic blockbusters coming off-patent.
There is a risk that the UK becomes a market used to build early volume, followed by withdrawal as more profitable markets emerge, report said.
In order to remain competitive, the UK could encourage the development and commercialisation of biosimilars for smaller markets.
This would build on the MHRA’s potentially game‑changing initiative of not requiring confirmatory studies, which although done for regulatory reasons and followed by the US FDA and European Medicines Agency, could have the consequence of significantly reducing the cost of making a biosimilar by as much as half. The impact of this will become clearer over the next few years, the report stated.
Medicines UK conducted this study in partnership with Aharav Consultants, and drew its findings from analysis of the company’s proprietary HORIZONS dataset.
