The United Kingdom risks missing out on substantial cost savings from biosimilar medicines due to uncertainties surrounding pricing and limited uptake within the National Health Service (NHS), according to a recent industry report. Medicines UK, representing the country’s generics and biosimilar manufacturers, warned that up to 50 complex biosimilar drugs may not be launched in the UK despite becoming available elsewhere in Europe and the United States.
Biosimilars are highly complex versions of biological medicines that have lost patent protection, often used to treat conditions such as cancer and autoimmune diseases. Unlike generic drugs, which are identical copies of original branded products, biosimilars are similar but not exact replicas, making their development more intricate and costly. Nonetheless, these medicines can offer significant savings to public health systems by providing lower-cost alternatives to expensive branded therapies.
The report highlights that between 2026 and 2032, 74 biological medicines are expected to lose patent protection, creating an opportunity for biosimilars to enter the market. However, approximately 50 of these are deemed unlikely to be introduced in the UK, including treatments like the cancer drug blinatumomab and cholesterol-lowering medicine alirocumab. One key obstacle is the limited current use of these branded drugs within the NHS, reducing the incentive for manufacturers to release lower-cost versions.
Sandoz, a leading biosimilar producer, cited government policies as a critical barrier to entry. Chief Executive Officer Richard Saynor pointed to the tax and payment rules that do not differentiate between original branded drugmakers and companies producing biosimilars. The existing tax clawback program, which reins in NHS medicine spending by requiring companies to rebate sales once expenditure limits are breached, applies equally to biosimilars and originator drugs. According to Saynor, this policy effectively taxes biosimilar makers as if they were originators, discouraging market entry.
Industry representatives also emphasized the regulatory complexity around pricing and NHS adoption. While the NHS and the drug cost regulator apparently recognize the value of off-patent medicines, engaging the Department of Health remains challenging. Discussions on reforming the pricing and tax structure are ongoing but do not currently include off-patent manufacturers.
The report notes that the 50 biosimilars at risk of being withheld from the UK market currently account for NHS spending of approximately £608 million ($806 million) annually, excluding confidential discounts. Proponents argue that introducing lower-cost biosimilars could increase patient access by improving cost-effectiveness, thereby expanding their use in the NHS. Past examples include expanded applications for the cancer drug bevacizumab and increased availability of adalimumab for rheumatoid arthritis following biosimilar introductions.
The NHS has acknowledged the potential for biosimilars to generate significant savings and has established frameworks to promote their use. With a growing number of biological drugs expected to lose patent protection in the coming years, ensuring a hospitable environment for biosimilars is likely to become an increasingly important issue for the UK’s healthcare system.