By Emily May, Research Analyst, and Karen Taylor, Director, Deloitte Centre for Health Solutions
Biosimilars are biological medicines made or derived from living organisms and comprise complex molecules that are highly similar and therapeutically equivalent to an approved reference biologic. As original biologics lose their patent protection, companies can develop biosimilar medicines in a shorter time frame and price them at around 20-30 per cent lower.1 The increased competition generated has the potential to deliver significant savings to healthcare systems. At last month’s Westminster Health Forum on ‘Priorities for biosimilars in the NHS’2 we discussed biosimilar competition, cost-effectiveness and access. This week’s blog summarises our related research on the benefits, market position and future implications of biosimilars for healthcare stakeholders.
Why should clinicians prescribe biosimilars?
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.3
Biosimilars, however, offer potential benefits to every stakeholder in the health system by providing a lower cost, but equally effective, treatment option. This allows more patients to be treated with the biosimilar than would be the case with the original reference biologic. The potential savings from the use of biosimilars can also fund other new treatments. In 2017-18, the NHS saved £324 million by switching from using ten expensive medicines to better value and equally effective alternatives, with an expectation that even more saving would be achieved in future years.4
Most health systems have developed protocols and incentives as well as diverse reimbursement and procurement policies to expand competition to ensure biosimilar uptake is optimised in order to capitalise on these potential savings.5 However, the decision to prescribe or switch to a biological medicine for an individual patient, whether an originator or biosimilar medicine, rests with the responsible clinician in consultation with the patient and their family/carers.
How has the prescribing of biosimilars evolved?
Biosimilars have been used in clinical practice for more than 14 years, following the European Union’s (EU) approval of the first biosimilar in 2006. The EU is now recognised as pioneering the regulation and approval of biosimilars worldwide.6 EU Marketing Authorisation applications for biotechnology-derived medicines, including biosimilar medicines, are by law reviewed centrally by the European Medicines Agency (EMA). This marketing authorisation is valid in all EU Member States and signifies the medicine can be prescribed confidently. Following the UK’s exit from the EU, the MHRA has published guidance for a new biosimilar licensing regime clarifying many post-Brexit requirements for biosimilar products.7
By 2021, the EMA had recommended the approval of 77 biosimilars, although eight were withdrawn after approval, leaving a total of 69 approved biosimilars.8 However, there is a substantial variation in adoption between and within European countries, with differences across therapeutic areas, as well as in the level of competition between reference biologics and biosimilars.9 Over the next 10 to 15 years, more than 30 biologics will lose market protection which will lead to further biosimilar competition in existing and new therapy areas, including for orphan indications. The new wave of biologics losing exclusivity between 2019 and 2023 is expected to save an estimated US$160 billion globally, with the biosimilar market tripling in size.10
What is the current EU market situation?
In Europe, biosimilars have captured ten per cent of the total biologics market by value, with the greatest uptake (seven per cent) in the past five years. This amount is substantially higher by volume, reflecting a steady increase in the level of savings due to growing biosimilar competition and penetration.11 Furthermore, over the past 10 years, the cumulative patient treatment days for EU-approved biosimilars has doubled roughly every 1.5 years with the total clinical experience now exceeding two billion patient treatment days in Europe.12
Cost-effectiveness and the future of the UK market
In 2017, the NHS ‘Commissioning Framework for Biological Medicines’ set a target for the NHS to adopt best value biological medicine in 90 per cent of new patients within three months of launch of a biosimilar, and at least 80 per cent of existing patients within 12 months, or sooner.13,14 This was a tough target and was not achieved with Remicade (took 28 months to reach 80 per cent) or Enbrel (after 12 months had reached only 50 per cent of eligible patients).15 When the next two biosimilars, the cancer drugs MabThera and Herceptin reached the market, Commissioning for Quality and Innovation (CQUIN) framework incentives, and close collaboration with the Cancer Vanguard and NHS Improvement, meant 80 per cent uptake was achieved in ten and eight months, respectively.16
A 2018 nationwide campaign to drive biosimilars uptake across the NHS aimed to save £500 million a year by 2021.17 The campaign exceeded this target with efficiency savings of £800 million a year and clinicians able to use this headroom to treat more patients.18 NHS procurement approaches comprise a sustainable tendering process, reflecting lessons from ‘early mistakes of a race to the bottom on price’.19 The NHS’s continuing encouragement of biosimilar adoption has resulted in the UK being Europe’s leading market for adoption, with between 86 to 90 per cent uptake of biosimilar versions of top-selling biologics.20
The UK biosimilars market is forecast to grow at a compound annual growth rate (CAGR) of 31.16 per cent from 2020 to 2028, with monoclonal antibodies being the highest contributor reaching $2,462.6 million by 2028. Oncological biosimilars are expected to be the highest contributor reaching $2,232.1 million.21
Over the next few years, the market share and associated savings from biosimilars are expected to grow at an exponential rate. Even as biosimilar regulatory approval becomes more streamlined, and new market barriers are overcome, NHS policy makers will need to continue developing evidence-based incentives, guidelines, procurement and engagement strategies to champion biosimilar prescribing. At the same time policy makers will need to be mindful of the need to balance this with incentivising innovation more generally. Ultimately however, introducing higher level of competition is an effective way of supporting innovation and balancing patient access and choice, whilst enabling the full cost-effectiveness of biosimilars to be realised.
1 NHS England » What is a Biosimilar Medicine?
3 Patient access to innovative medicine in Europe (January 2019)
4 NHS England » What is a Biosimilar Medicine?
5 15 years of biosimilar access in Europe - PharmaTimes Magazine April 2021
6 Biosimilars in the EU - Information guide for healthcare professionals (europa.eu)
7 UK releases post-Brexit biosimilar guidelines / Guidelines / Home - GaBI Online - Generics and Biosimilars Initiative
8 Biosimilars approved in Europe / General / Biosimilars / Home - GaBI Online - Generics and Biosimilars Initiative
9 15 years of biosimilar access in Europe - PharmaTimes Magazine April 2021
10 The Global Use of Medicine in 2019 and Outlook to 2023 - IQVIA
11 15 years of biosimilar access in Europe - PharmaTimes Magazine April 2021
12 The total clinical experience with biosimilar medicines exceeds 2 billion patient treatment days | Medicines for Europe
13 biosimilar-medicines-commissioning-framework.pdf (england.nhs.uk)
14 NHS England targeting £150 million in savings through rapid adoption of biosimilar adalimumab - Two Labs Pharma Services
15 Biosimilars in the UK: where are we now and where does the NHS want to go? - (pharmaphorum.com)
16 Biosimilars in the UK: where are we now and where does the NHS want to go? - (pharmaphorum.com)
17 NHS England » Biosimilar medicines
18 Can Biosimilar Orphans Increase Health System Sustainability In The UK? :: Pink Sheet (informa.com)
20 New Herceptin biosimilar launched in UK (biopharma-reporter.com)
21 Europe Biosimilars Markets Databank: Markets Databank by MAGNA, February 2021