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Monday September 28 2026

UK risks ‘biosimilar void’ despite golden age of biologic loss of exclusivity

The UK is entering a golden age of potential biosimilar launches, with 74 major biologic medicines – including weight loss treatment semaglutide – set to lose exclusivity between now and 2032. But without decisive action, the NHS risks facing a growing ‘biosimilar void’ as manufacturers struggle to recoup of cost of bringing a biosimilar to market, according to new research from Medicines UK.

UK Entering a Golden Age of Potential Biosimilar Launches

The UK is entering a golden age of potential biosimilar launches, with 74 major biologic medicines – including weight‑loss treatment semaglutide – set to lose exclusivity between now and 2032. But without decisive action, the NHS risks facing a growing ‘biosimilar void’ as manufacturers struggle to recoup of cost of bringing a biosimilar to market, according to new research from Medicines UK. And where significant global demand does exist for the high-value biosimilars, another challenge is that manufacturers prioritise more profitable markets in the EU and US.

This emerging biosimilar 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.

These findings are published today in a new study from Medicines UK, produced in partnership with Aharav Consultants and draws its findings from analysis of the company’s proprietary HORIZONS® dataset.

A transformative period for biologics – but the UK may miss out

Between 2026 and 2032, 74 significant biologic products will lose exclusivity. A further 24 biologics are regarded as having very low sales anywhere in the world and will not see biosimilar competition globally. Biosimilars are developed and commercialised based on global market opportunity, with development costs now averaging more than £200m. Confirmatory phase III trials – which many regulators are moving away from – currently account for roughly half of these costs.

The report categorises the 74 biologics into two groups:

Category 1: High‑value UK targets with annual sales above $50m (£37.5m).
Category 2: Products with limited UK commercial opportunity due to low NHS usage, despite significantly higher sales in the EU and US.

Category 1: High‑value UK biologics

The analysis identifies 24 core products poised for genericisation, with several key findings:

Harmonised launch timelines: 23 of the 24 products share identical UK and EU patent expiry dates.
Divergence with the US: For 7 products, UK launches are likely to occur earlier than in the US; for 10 products, US launches may come first due to different IP strategies. However, litigation and settlements could delay nearly half of the molecules where the US theoretically has an earlier launch advantage.
Major revenue shifts:

2028: High‑value entries worth approximately $880m (£656m).
2031: A significant shift of around $3bn (£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.

Category 2: The UK ‘value gap’

The remaining 50 biologics each have annual UK sales below $50m (£37.5m). However:

EU market: 29 of these 50 biologic products exceed $100m (£75m) in annual sales, with a combined brand value of $10.4bn (£7.8bn).
US market: 34 products exceed $100m (£75m), totalling $27bn (£20.3bn).
UK market: These same products have total annual NHS sales of just $810m (£608m), excluding confidential discounts – a cost borne every year until patent expiry.

While the UK is a smaller market, the report suggests low usage may reflect value‑for‑money access restrictions rather than limited clinical need.

A strategic opportunity – if the UK acts

There is a chance for the UK to piggyback on a proportion of category 2 biosimilars launching. This is especially the case where high-value biosimilar opportunities exist in the Europe, and where almost universally, patent expiry dates appear to align or broadly align. This is perhaps less likely with the US, since there is a greater divergence between US and UK patent expiry dates, owing to the US patent dance and consequent litigation and settlement agreements.

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.

The UK is currently one of the leading markets for biosimilar uptake, with products such as ustekinumab and aflibercept performing strongly compared to most European countries in terms of recent patient switching following loss of exclusivity.

The report states the UK market is attractive for two reasons. First, biosimilars have been made a clear national priority, with public targets and pro‑biosimilar policies promoted by politicians and NHS leaders. Second, the UK (particularly England) offers large volumes and increasingly rapid uptake of biosimilars following loss of exclusivity, even though UK biosimilar prices are comparatively low and price erosion has become similar to that seen in generic markets.

However, the report warns that relying solely on the UK’s sizeable and fast uptake as its USP carries risks. Comparable European nations are actively seeking to increase biosimilar penetration; France and Germany have both introduced more pro‑biosimilar policies this year. Europe has historically led on biosimilars, while the US – the world’s largest and most profitable pharmaceuticals market – has lagged. This may be about to change, in which case finite biosimilar manufacturing capacity, will increasingly be prioritised to meet US demand. This could apply to the biologic blockbusters coming off-patent, where the global demand and return on investment is clear. Here, there is a risk that the UK becomes a market used to build early volume, followed by withdrawal as more profitable markets emerge.

Mark Samuels, Chief Executive, Medicines UK

Mark Samuels, chief executive of Medicines UK, 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.

“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.

“For the past 30 years, the NHS and other developed world healthcare payers have been able to control pharmaceutical spending by relying on generic medicines to bring prices down following patent expiry. Left unchecked, the Biosimilar Void is likely to destroy this expectation. The missed opportunities are likely to proliferate in the next decade, the same period covered by the UK’s agreement with the US to spend more on pharmaceuticals, and in particular, patented medicines.”

Strengthening the UK’s position

The report shows that the UK can 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.

Ultimately, to remain competitive, the UK must ensure its internal market stays attractive as biosimilar demand grows elsewhere, and that domestic supply constraints and withdrawals are minimised by securing the capacity the NHS and patients need.

Practical measures to support these objectives include:

Ensuring the UK Government and NHS continue to communicate clearly that the absence of phase III trials as routine is a regulatory decision and does not imply biosimilars are inferior to originators.
Following Health Canada’s approach of presuming confirmatory studies will not be required before a biosimilar is licensed in the UK.
Considering the impact of VPAG, which applies a significant clawback to NHS biosimilar sales, particularly for lower‑value markets and can impact the attractiveness of supplying high-value biosimilars to the UK over a sustained period.
Building on commitments to enhance horizon‑scanning and lengthen tender lead times by publishing an NHS priority list of lower‑value biosimilars, including those where patient cohorts could grow through more affordable versions and NHS switching incentives.
Expanding the centrally developed gainshare agreement – currently focused on high‑value biosimilars – to include lower value priorities, signalling clear support for switching when cost‑effective competition emerges.
Deploying a small portion of the UK’s research architecture to support biosimilar research, including encouraging applications for biosimilars where none exist (including biosimilar cell and gene therapies).
Considering whether existing UK stakes in domestic manufacturing could be efficiently redirected to support biosimilar development.

Author

Jeremy Durrant
Communications and Engagement Director

Jeremy oversees all strategic communications engagement and delivery on behalf of the association. A former journalist at the start of his career, he spent 16 years as a partner in a London-based international strategic communications consultancy leading and advising on high-profile media campaigns and running a risk and crisis practice.