Table of Contents
- Key Points
- Why This Review Matters for Patients
- The Rising Cost of Biologic Medicines
- How the Research Was Conducted
- Current Status of Biosimilars: Numbers Worldwide
- What Has Been Achieved with Biosimilars
- Spotlight on the United Kingdom (UK) Experience
- Clinical Implications: What This Means for Patients
- Limitations of This Review
- Key Takeaways for Patients
- Frequently Asked Questions
- Source Information
Key Points
- Biosimilars are near-identical, lower-cost versions of biologics, with no clinically meaningful differences in effectiveness or safety.
- Biosimilar savings have expanded patient access, allowing earlier biologic treatment in conditions like rheumatoid arthritis and cancer.
- In the UK, biosimilar savings funded the Cancer Drugs Fund, which paid for CAR T-cell therapy for some lymphoma patients.
- Real-world UK evidence showed biosimilar filgrastim use more than doubled after guidelines moved it to first-line cancer therapy.
- Because biosimilars add suppliers, they help secure the medicine supply and prevent shortages that can interrupt treatment.
Why This Review Matters for Patients
Biologic medicines (large, complex protein drugs made from living cells) have transformed the treatment of many cancers and immune-mediated inflammatory diseases. Yet their high cost places an enormous strain on healthcare systems — a burden that is ultimately passed on to patients through limited access, delayed treatment, or out-of-pocket expenses.
The review opens with an acknowledgment: biosimilars are widely hailed as a pharmaceutical success story. But doubts remain over whether they deliver enough "value" — beyond savings — to justify the effort of changing entrenched prescribing habits. This review was written to answer that question.
The Rising Cost of Biologic Medicines
In 2023, biologics accounted for 40% of all medicine spending in the European Union — approximately €87.6 billion — and forecasters expect this number to keep climbing. In the United States, biologics account for 38–40% of all pharmaceutical spending.
Three forces are pushing costs upward: population growth and aging (which increase rates of chronic disease and cancer), the arrival of new therapies with entirely new mechanisms of action, and the limited availability of biologics in many countries. The authors report that, in many regions, some patients are prevented from receiving prompt treatment, are less likely to receive optimal doses, or struggle to continue appropriate therapy — purely because of cost and access barriers.
This matters because healthcare sustainability is essential: health services must be able to deliver high-quality care both now and in the future. Biosimilars, the article argues, are a key tool for achieving this without sacrificing quality.
How the Research Was Conducted
The authors performed a narrative literature search on 13 July 2023. They searched the MEDLINE database (a large medical research database) using terms including: biosimilar AND access OR benefit OR capacity OR cost OR finan* OR nurse OR outcome OR value OR saving OR sustain*, with results limited to the years 2010–2023.
They also manually reviewed abstracts presented at major medical congresses, including the European Crohn's and Colitis Organisation, the European Alliance of Associations for Rheumatology, the European Association of Hospital Pharmacists, the European Academy of Dermatology and Venereology, the American Society of Clinical Oncology, and the European Society of Medical Oncology. These manual searches were limited to the period January 2020–December 2023.
Articles were selected if they reported data from real-world studies (evidence from everyday clinical practice, not just controlled trials) in two areas: oncology (including any hematological malignancy, meaning cancers of the blood or bone marrow) and immune-mediated inflammatory diseases such as Crohn's disease, ulcerative colitis, ankylosing spondylitis, axial spondyloarthritis, psoriasis, psoriatic arthritis, and rheumatoid arthritis.
Current Status of Biosimilars: Numbers Worldwide
Biosimilars are not a niche product category. As of April 2025, the numbers are striking:
- The European Medicines Agency (EMA) — Europe's medicines regulator — has recommended approval of 106 biosimilars.
- The United States Food and Drug Administration (FDA) has licensed 72 biosimilars.
The first biosimilar was approved in 2006 — the growth hormone medicine somatropin (brand name Omnitrope), approved by the EMA on 12 April 2006. Since then, biosimilars have been approved across a wide range of therapy areas, including:
- Immune-mediated inflammatory diseases: biosimilars of adalimumab (Humira), infliximab (Remicade), etanercept (Enbrel), rituximab (Rituxan), tocilizumab (Actemra), and ustekinumab (Stelara)
- Cancers: biosimilars of bevacizumab (Avastin), trastuzumab (Herceptin), and rituximab — used for breast cancer, gastric cancer, and blood cancers
- Eye conditions: biosimilars of aflibercept (Eylea) and ranibizumab (Lucentis) for retinal disease
- Diabetes: biosimilars (also called follow-on biologics) of insulin glargine, insulin lispro, and insulin aspart
- Blood cell support: filgrastim and pegfilgrastim biosimilars for neutropenia (low white blood cell counts), and epoetin biosimilars for anemia
- Bone health: denosumab, teriparatide biosimilars for osteoporosis
- Other conditions: multiple sclerosis (natalizumab), asthma and hives (omalizumab), blood disorders (eculizumab), fertility treatment (follitropin alfa)
Many more are in the pipeline. According to the review's Table 2 (data limited to publicly disclosed information), biosimilars in phase III clinical trials or under regulatory review include versions of some of today's most expensive biologic medicines, such as adalimumab, rituximab, and trastuzumab; key newer targets are the cancer immunotherapies nivolumab (Opdivo) and pembrolizumab (Keytruda), secukinumab (Cosentyx), and vedolizumab (Entyvio). This indicates the biosimilar field is expanding into even the most sophisticated treatment areas.
What Has Been Achieved with Biosimilars
The review identifies several distinct achievements that extend well beyond cost savings. First, biosimilars trigger a price competition effect: when a biosimilar enters the market, the manufacturer of the original (reference) medicine often lowers its own price or offers discounts. This saves money across the whole class of medicines, even for patients who stay on the originator product.
Second, these savings expand treatment options and improve access for patients who previously could not receive biologics — for example, people who faced out-of-pocket expenses or restrictive local approval criteria. In various jurisdictions, patients only gain access once a product is added to the formulary (the official list of covered medicines), and that access can be limited by local approval rules. Biosimilars loosen those restrictions.
Third — and importantly for patients — cost reductions are changing treatment guidelines. Many guidelines recommend early (first-line) treatment with biologics, but patients have often been denied these medicines because of cost. With biosimilars, biologic therapy is being moved to earlier disease stages. This matters because early intervention can prevent disease complications, improve options for later treatment, and improve overall quality of life. It can even save money later by avoiding expensive second- and third-line therapies and complications.
The review also highlights an often-overlooked indirect benefit: surety of supply. Biologic medicines are complex to manufacture, with specialized production processes, and it can be difficult to rapidly boost production when demand spikes. Having more suppliers — including biosimilar manufacturers — helps prevent medicine shortages.
However, the authors are candid about challenges. Tendering (a process where healthcare systems put contracts out to bid and often award them to the single lowest bidder) can reduce competition and create drug shortages if one product becomes suddenly popular. If a losing manufacturer withdraws from the market entirely, prices can eventually rise because of the lack of competition. The review notes that splitting tender awards allows for competition and maintains supply, although it may reduce the size of up-front savings.
What Has Been Achieved in the United Kingdom
The UK is the review's central case study, and its experiences offer the clearest evidence that biosimilar savings change patient lives.
Moving Filgrastim to First-Line Treatment
After biosimilar filgrastim (a medicine that boosts white blood cell production) launched in the UK in 2008, the country's guidelines for granulocyte colony-stimulating factor (G-CSF) medicines were reassessed. Guidance in several English Strategic Health Authorities was updated to reflect the improved cost-effectiveness of biosimilar filgrastim compared with alternatives. G-CSF was then moved to first-line cancer therapy (meaning it became a standard early treatment rather than a reserved option).
The result: utilization of both the reference and biosimilar filgrastim products rose by 104% between January 2009 and January 2014 — utilization more than doubled, representing a significant group of patients who previously may not have been able to access the treatment at all.
Expanding Access to Biologics in Rheumatoid Arthritis
Treatment guidelines in the UK also changed for patients with rheumatoid arthritis (RA), a chronic autoimmune disease causing joint pain and damage. The National Institute for Health and Care Excellence (NICE) — the UK's health technology assessment body — previously recommended that patients with RA receive biologic treatments only if they had severe disease. The "financial windfall" created by biosimilars allowed this restriction to be loosened, so patients could access biologics earlier in their disease course.
Setting National Targets for Biosimilar Adoption
Learning from earlier experience with biosimilar filgrastim, England's National Health Service (NHS) encouraged collaboration between regional trusts (hospital networks) and local commissioning groups — with benefit sharing (a system where savings are partly reinvested in patient care) offered as an incentive. In this collaboration, the NHS set targets:
- At least 90% (9 in 10) of new patients should be prescribed the biologic offering the best value, within 3 months of a biosimilar's launch.
- At least 80% (8 in 10) of existing patients should be switched within 12 months — or sooner if possible.
Funding Innovation: The Cancer Drugs Fund
In 2018, NHS England reinvested biosimilar savings into the Cancer Drugs Fund — a program created to reimburse timely access to promising new cancer medicines. Its annual budget of £320 million is fully covered by savings from just ten patent-expired medicines. This fund was designed for novel agents where long-term cost-effectiveness evidence does not yet exist.
The approach has had measurable effects: the NHS became one of the three fastest-adopting healthcare systems for treatment innovation globally, and more than 80,000 patients have so far benefited from the scheme.
Perhaps the most striking example of biosimilar savings reinvested: the NHS became the first healthcare system in Europe to reimburse tisagenlecleucel — a chimeric antigen receptor (CAR) T-cell therapy in which a patient's own immune cells are engineered to attack cancer. It is used in England and Wales for people with diffuse large B-cell lymphoma who have not responded to two or more prior treatments. The drug has a list price of £282,000 for a single intravenous injection, and it is paid for through the Cancer Drugs Fund — money that exists because of biosimilar savings.
A Hospital-Level Example: Cardiff
Biosimilar savings also benefit patients directly at the hospital level. In one hospital in Cardiff, Wales, savings from switching patients from subcutaneous (under-the-skin, self-injected) reference rituximab to intravenous (IV, given through a drip) rituximab biosimilar were estimated at £300,000–£335,000. These funds were reinvested in services that benefit patients, demonstrating that savings translate into visible improvements in day-to-day care.
Clinical Implications: What This Means for Patients
For an individual patient, what does all this mean in practice? The review offers several concrete answers. The findings suggest that biosimilars increase the availability of biologic medicines for earlier lines of therapy — so instead of waiting until disease has progressed, patients with conditions such as rheumatoid arthritis, inflammatory bowel disease, or cancer may receive biologic therapy sooner.
Better yet, expanded access can reduce overall disease burden. Patients who respond well to a biologic not only feel better — they are less likely to suffer the complications, hospital stays, and follow-up treatments that come with undertreated disease. This improves the entire patient experience, not just the prescription.
The review also notes that cost savings have been used to improve the broader care ecosystem: optimizing treatment pathways, providing value-added services to support patient care, and enabling hospitals to reinvest in services and research. For patients, this can mean better-coordinated care, shorter delays, and access to innovative new medicines that otherwise would not be affordable.
Patients should be aware, however, that biosimilars are not "generic" versions of biologic medicines in the traditional sense. A biosimilar is a highly similar copy that has been shown to have no clinically meaningful differences in efficacy (how well it works) or safety (side effects) compared with its reference biologic. Regulatory approval by the EMA and FDA requires rigorous evidence of this equivalence.
Limitations of This Review
The authors acknowledge important limitations of their analysis. Most of the real-world examples came from Europe — and the authors state they cannot fully explain this publication bias, though they suspect it is partly because fewer biosimilars are available in lower-income countries. Healthcare systems in high-income countries face unique financial pressures that make biosimilars particularly appealing, so the evidence base is skewed toward wealthy nations.
Because this is a narrative review based on a literature search, rather than a systematic meta-analysis pooling patient-level data, the findings describe patterns and case examples rather than providing a single pooled statistical effect. Also, because the search was limited to publications from 2010–2023 and congress abstracts from January 2020–December 2023, very recent adoption successes or failures may not be captured. Data for biosimilars in development (Table 2) were limited to publicly disclosed information and may not reflect all ongoing research.
Finally, the article focuses on oncology and immune-mediated inflammatory diseases, so its conclusions about patient benefit do not necessarily extend to other biosimilar product categories, such as ophthalmology (eye treatments) or endocrinology (hormone and diabetes treatments).
Key Takeaways for Patients
If you or a family member is prescribed a biologic medicine — or if your doctor suggests switching to a biosimilar — this review suggests several practical points to keep in mind:
- Switching is supported by evidence. The review's real-world case studies (which are reinforced by decades of regulatory oversight of biosimilars) found no clinically meaningful differences in effectiveness or safety between reference biologics and their biosimilars.
- Biosimilars do not mean lower-quality care. Because biosimilars free up healthcare budgets, hospitals and health systems often use the savings to fund earlier treatment, additional nursing support, and new therapies.
- Earlier access can change outcomes. In conditions like rheumatoid arthritis and cancer, starting biologic treatment earlier — often made possible by biosimilar affordability — is associated with better control of disease and prevention of complications.
- If a medicine shortage is a concern, biosimilars can help. By increasing the number of suppliers, biosimilars contribute to a more secure medicine supply chain, reducing the risk of treatment interruptions.
- Don't assume the most expensive medicine is the best one for you. Ask your doctor direct questions: Is this biosimilar appropriate for my condition? What evidence supports its use? How will my response be monitored after switching? Your care team should be able to offer clear answers.
Frequently Asked Questions
What is a biosimilar, and is it as safe and effective as the original biologic?
A biosimilar is a highly similar copy of a biologic medicine. Regulatory approval by the EMA and FDA requires evidence showing no clinically meaningful differences in how well it works or its side effects. Real-world case studies found no meaningful differences in effectiveness or safety between reference biologics and their biosimilars.
Will switching from my current biologic to a biosimilar mean lower-quality care?
No. Biosimilars are not lower-quality medicines. They free up healthcare budgets, which hospitals and health systems often use to fund earlier treatment, nursing support, and new therapies. This can improve overall patient experience. Ask your doctor if a biosimilar is appropriate for your condition.
Could a biosimilar help me start biologic treatment earlier in my disease?
Yes. Biosimilar cost savings have changed treatment guidelines, allowing biologic therapy to be moved to earlier disease stages in conditions like rheumatoid arthritis and cancer. For example, in the UK, this led to more than double the use of filgrastim and earlier access to biologics for rheumatoid arthritis patients.
Why are biosimilars cheaper, and how does that affect my treatment options?
When a biosimilar enters the market, the original manufacturer often lowers its price. This saves money across the whole class of medicines, expanding treatment options for patients who previously faced access barriers. Savings have also funded entirely new cancer treatments, like CAR T-cell therapy in England.
Is it safe to switch back and forth between a biologic and its biosimilar?
The review's real-world case studies found no clinically meaningful differences in effectiveness or safety when switching compared with staying on the reference biologic. However, every patient is different. Talk to your doctor about whether switching is appropriate for you and how you will be monitored.
How do biosimilars affect medicine shortages and supply reliability?
Biosimilars increase the number of suppliers of a medicine. This helps prevent drug shortages because production can be adjusted across multiple manufacturers. However, if healthcare systems award contracts to a single lowest bidder, and that manufacturer withdraws, prices can rise. Splitting contracts helps maintain supply.
If my doctor recommends switching me from my current biologic to a biosimilar, when should I get a second opinion?
A second opinion can help when a switch is proposed and you want to confirm the biosimilar is appropriate for your condition, what evidence supports its use, and how your response will be monitored afterward. Real-world case studies found no clinically meaningful differences in effectiveness or safety between reference biologics and their biosimilars, and switching is supported by evidence. Because every patient is different, an independent review of your records can clarify whether switching or staying on your current biologic fits your situation. Diagnostic Detectives Network provides independent expert second opinions.
Source Information
This patient-friendly article is based on peer-reviewed research originally published as:
"Beyond Cost: Observations on Clinical and Patient Benefits of Biosimilars in Real-World Settings" by Tore K. Kvien, Neil Betteridge, Ines Brückmann, Wolfram Bodenmüller, Galyna Bryn, Silvio Danese, João Gonçalves, Zorana Maravic, Carter Thorne, Laura Wingate, and Paul Cornes.
The original article was published in BioDrugs (2025), volume 39, pages 537–553 (https://doi.org/10.1007/s40259-025-00727-z), accepted 5 May 2025 and published online 5 June 2025. Funding and author affiliations are disclosed in the original publication. The authors include clinicians, patient organization representatives, and pharmaceutical industry employees; as with all secondary summaries, readers should consult the original article and their qualified healthcare provider for guidance on individual medical decisions.
