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Developing biosimilars of medicines that are due to come off patent could save the NHS up to £40m per year on average, a Medicines UK report has said.
In its ‘UK biosimiliar void report’, published on 28 September 2026, Medicines UK — the generics and biosimilars manufacturers association — said that 74 major biologic products are expected to come off patent between 2026 and 2032. Of these, 50 products currently have annual UK sales of less than US$50m (£37.5m).
“By prioritising these molecules, developers can (depending on the effectiveness of the treatment) potentially unlock massive latent demand; discounted biosimilars can trigger a review of clinical patient treatment pathways,” the report said.
“This may lead to a shift in their use from last-resort to early-line therapy, transforming niche products into high-volume commercial successes while significantly reducing NHS treatment costs.”
In the report, Medicines UK asked if more should be done to encourage development of biosimilars of these products for the UK market — including the two-thirds of products with annual UK sales below US$50m (£37.5m) — as well as what would need to be done to help this happen.
Medicines UK members made several suggestions, including that NHS England should publish a list of upcoming lower-value biologic patent expiries, the report noted. It added that this list could include biosimilars “for which the patient cohort could grow through the supply of more affordable versions and which could benefit from NHS switching incentives”.
A spokesperson for NHS England told The Pharmaceutical Journal in February 2025 that switching from original biologic to biosimilar medicines could save the NHS £1bn over five years.
The report also highlighted that in the UK, confirmatory phase III trials — which can make up to half the cost of a drug development and licensing process — are no longer automatically required for a biosimilar licence application. The Medicines and Healthcare products Regulatory Agency (MHRA) was the first major regulator not to require confirmatory studies, it continued.
However some Medicines UK members were concerned that “the lack of routine phase III trials to demonstrate similarity with the reference product, a decision taken by MHRA and followed by other leading regulators, could lead to the misconception that biosimilars are of lesser quality than the originator version”, according to the report.
To address this lack of routine phase III trials, the report recommended that the MHRA — together with the Office for Life Sciences and the NHS — should take an “aligned approach” to emphasise that the decision to remove the need for confirmatory studies is “based on regulatory experience and on what is required to successfully demonstrate similarity with the reference product”.
“A failure to do so could allow this change, begun by the MHRA and followed by other leading regulators, to wrongly infer biosimilars as being of lower quality,” the report added.
Medicines UK members also suggested that the government should “explore whether existing publicly funded domestic manufacturing could be efficiently redirected to support biosimilar development”.
Mark Samuels, chief executive of Medicines UK, commented: “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.”
An MHRA spokesperson said: “The MHRA continues to speed up access to medicines for patients, increase efficiency of regulation and help to attract innovation and investment in the UK’s thriving £100bn life sciences industry.
“The biosimilar market is an integral and growing part of our healthcare system, and we are in the process of reviewing Medicines UK’s latest report and will respond in due course.”
