United Kingdom Biosimilars Market Overview, 2030

Biosimilars are a type of biological medicine and are widely used in the UK for many conditions. Biological medicines are complex medicines made or derived from a biological source. The biosimilar contains a version of an active substance of an already approved biological medicinal product, known as the reference product. Offering the same clinical effectiveness and safety as their reference products, biosimilars are interchangeable with the original biological medicine and other biosimilars when approved. More biosimilars are expected to come to market in the coming years, with the patents of more than 80 biological medicines set to expire between 2023 and 2027. The rate of uptake of biosimilars has accelerated as stakeholders have become increasingly comfortable with these products. Over the last six years there has been significant growth in the uptake of biosimilars in the UK, and it is clear there is significant development potential in the coming years. There are clear opportunities to maximise the biosimilar industry’s potential NHS and patient benefits in the UK. However, the adoption of biosimilars is lower in regions experiencing low social and governmental trust. In an era of significant economic, demographic, scientific and technological challenge, health economies need to ensure quality outcomes and value for money from prescribing. While biological medicines have revolutionised patient treatment by offering new, more effective medicines for acute and chronic conditions (such as neutropenia, cancer and a wide range of inflammatory and autoimmune diseases), the cost is often seen as a barrier to access.

According to the research report, “United Kingdom (UK) Biosimilars Market Overview, 2030” published by Bonafide Research, the United Kingdom Biosimilars market is projected to add USD 2.05 Billion market size from 2025 to 2030. Biologics target specific immune proteins to reduce inflammation but are expensive and often used after other treatments fail. Biosimilars entered the UK market beginning in 2006, allowing earlier treatment and expanded access. Unlike generic drugs, biosimilars are not identical to their reference biologics, which has caused concerns about the safety of switching to biosimilars among providers and patients. In November 2022, the UK’s Medicines and Healthcare products Regulatory Agency updated its guidance on licensing biosimilar products, stating that authorized biosimilars are interchangeable with their reference products and other biosimilars to the same reference product. This means prescribers can expect the same therapeutic effect when switching between them, making such switches standard clinical practice. However, switching safety concerns persist. Due to a number of causes, including the expiration of biologic medication patents, rising healthcare costs, and government attempts to promote the use of biosimilars, the UK biosimilar industry has been expanding significantly in recent years. Because they provide a more affordable alternative to their reference products, biosimilars are playing a bigger role in the UK healthcare system. The number of biosimilars available in the UK is expected to increase with biosimilars entering a much wider range of therapy areas, including rheumatoid arthritis, oncology and diabetes. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance to ensure effective safety monitoring and tracking in accordance with EU pharmacovigilance legislation that came into force in July 2012. This includes a recommendation to capture brand name and batch number when reporting suspected adverse reactions. The ABPI and BIA recommend that biological medicines should be prescribed by brand name and not by INN.

The market is also confronted with difficulties including complicated regulatory requirements, expensive development and manufacturing costs, low patient and healthcare provider knowledge and acceptability, and competition from novel biologic therapies. However, the UK government is taking steps to encourage the use of biosimilars, including offering training and awareness campaigns for patients and healthcare professionals. Oncology, rheumatology, and gastroenterology are the top three therapeutic fields for biosimilars in the UK. In the UK, the National Health Service (NHS) is the primary payer for biosimilars, and the National Institute for Health and Care Excellence (NICE) oversees reimbursement through the Health Technology Assessment (HTA) procedure. As more biologic medications lose their patent protection and biosimilar producers continue to develop and enhance their products, the UK biosimilar industry is anticipated to expand. Additionally, anticipated to fuel market expansion in the upcoming years are the government's continued efforts to encourage the usage of biosimilars. The regulation of biosimilars in the UK is overseen by the Medicines and Healthcare Products Regulatory Agency (MHRA). Biosimilars must demonstrate that they have similar quality, safety, and efficacy to the reference product through a rigorous regulatory process that includes analytical, non-clinical, and clinical studies. The reimbursement of biosimilars in the UK is managed by the National Institute for Health and Care Excellence (NICE) through the Health Technology Assessment (HTA) process. NICE evaluates the clinical and cost-effectiveness of new drugs, including biosimilars, to determine whether they should be reimbursed by the National Health Service (NHS).

Erythropoietin (EPO) biosimilars are experiencing significant growth in the United Kingdom's biosimilars industry, driven by a confluence of clinical, economic, and regulatory factors. This surge is primarily attributed to the increasing prevalence of anemia associated with chronic kidney disease (CKD) and cancer, conditions that necessitate effective erythropoiesis-stimulating agents. As the UK's population ages, the incidence of CKD and cancer rises, thereby escalating the demand for EPO therapies. Biosimilar versions of EPO offer a cost-effective alternative to originator biologics, providing similar therapeutic outcomes at reduced costs, which is particularly appealing to the National Health Service (NHS) amid budgetary constraints. The European Medicines Agency (EMA) and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) have established rigorous yet streamlined approval processes for biosimilars, ensuring their safety and efficacy, and fostering confidence among healthcare providers and patients. Additionally, the expiration of patents for original EPO products has opened the market to biosimilar manufacturers, intensifying competition and further driving down prices. Educational initiatives aimed at healthcare professionals have also played a role in increasing the adoption of EPO biosimilars by highlighting their clinical equivalence to reference products.

Chronic and autoimmune disorders are growing with a high CAGR in the UK biosimilars industry due to the increasing prevalence of these conditions, the high cost burden of biologic treatments, and supportive health system policies aimed at promoting biosimilar uptake. Diseases such as rheumatoid arthritis, psoriasis, Crohn’s disease, and multiple sclerosis require long-term and often lifelong use of biologic drugs, particularly monoclonal antibodies and cytokine inhibitors. These originator biologics are expensive, and as healthcare costs rise in the UK, the National Health Service (NHS) has prioritized biosimilars as a strategic tool to deliver high-quality care while controlling expenditure. The expiration of patents for major biologics used in autoimmune disorders such as adalimumab, infliximab, and etanercept has paved the way for a growing number of biosimilar entrants, offering clinically equivalent alternatives at substantially lower costs. NHS England has launched multiple initiatives to encourage the switching of patients from originators to biosimilars, with specific targets and incentives tied to best-value biological prescribing. These efforts are supported by evidence from real-world data and clinical trials that confirm the safety, efficacy, and immunogenicity profiles of biosimilars in treating chronic and autoimmune conditions. Additionally, rising awareness among clinicians and patients about the benefits of biosimilars along with growing manufacturer investment in patient education and support programs has further accelerated their adoption. As the population ages and the incidence of chronic autoimmune diseases continues to rise, the demand for affordable biologic therapy is expected to surge, making this therapeutic area a key growth engine within the UK’s expanding biosimilars market.

Contract Research and Manufacturing Services (CRAMS) are growing with a high CAGR in the UK biosimilars industry due to a combination of economic efficiency, regulatory complexity, and strategic industry shifts favoring outsourcing. Developing and manufacturing biosimilars is a highly technical, resource-intensive process that requires specialized infrastructure, regulatory expertise, and significant financial investment. Many biosimilar developers in the UK particularly small and mid-sized firms lack the capacity to manage these demands in-house, leading to increased reliance on CRAMS providers. These service providers offer end-to-end solutions including preclinical research, clinical trials, regulatory submission support, and large-scale biologics manufacturing, all of which are essential for bringing a biosimilar to market efficiently and cost-effectively. The UK has a strong ecosystem of contract development and manufacturing organizations (CDMOs), supported by world-class academic research, a robust regulatory framework, and a government committed to advancing life sciences. Post-Brexit, the UK has also sought to reinforce its biopharmaceutical sector by fostering innovation and partnerships through initiatives such as the Life Sciences Vision and investment in biomanufacturing hubs. CRAMS providers benefit from this momentum, offering scalable and flexible solutions to biosimilar companies looking to mitigate risk, reduce time-to-market, and comply with evolving MHRA and international regulatory standards. Furthermore, the growing pipeline of biosimilars targeting complex biologics including monoclonal antibodies and fusion proteins has intensified the demand for advanced manufacturing capabilities and quality assurance, both of which CRAMS firms are well-positioned to deliver. Show more