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Medicines for Europe recently drew attention to a study showing that people living with rheumatoid arthritis (RA) in some lower income European countries couldn’t access treatment due to the cost of the biologic medicine they needed.1
The same organization also reported that between 2006 and 2020, European healthcare systems had been able to reinvest $18 billion in savings made from prescribing biosimilar medicines.1
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If you’ve never heard of a ‘biologic*’ or didn’t know that biosimilar medicines offer hard-pressed healthcare systems a way to:
- Stimulate innovation and adoption of value-added extras to improve patient care
- Broaden and accelerate patient access to more affordable licensed therapies
- Increase competition into the medicines’ market, which can lead to lower costs
- Generate savings that can be redirected towards other healthcare priorities
Biosimilars bring all of this, and still deliver the same safety, quality and efficacy as their reference medicine to ensure patient benefit.
What is a biosimilar?
A biosimilar is a successor to a biological medicine (also known as a ‘reference medicine’)2 for which the patent has expired and exclusivity has been lost. Today, they are available for patients with a wide range of chronic illnesses. 2,5
Biosimilars are more affordable treatment options that work in the same way and match the reference medicine in terms of quality, safety and efficacy.3,4 By their very nature, biological medicines have subtle differences and therefore no two batches are ever the same – but tight regulations ensure that the medicine works the same way each time.
To find out more about biosimilars, watch our short series of videos
Over the next decade, around 120 biologic medicines will lose their exclusivity.20 This opens the door for more patients living with different conditions to benefit from biosimilars. However, if we are to realize all the benefits of biosimilars, action is needed to unlock their full potential.
The pressure on healthcare systems
The world’s population is growing and aging.6 As a result, multiple chronic conditions (MCCs) are becoming more common – around one in every three adults are living with an MCC.7 The increased healthcare spending associated with treating MCCs puts further pressure on already strained healthcare systems.8
And the pressure continues to rise – global spending on healthcare is expected to reach $24.24 trillion by 20409 with the cost of biologic medicines accounting for a substantial proportion of this expenditure.10
Technology is advancing, treatments are becoming more targeted and their prices are increasing. In addition, the use of biologics is expanding into more therapy areas. For example, by 2026, 57% of the total spent on prescription and over-the-counter (OTC) sales will be on biologics, which is estimated at $4.9bn.11 So while these advanced medicines have revolutionized treatment, the cost of biologics has also had a big financial impact on healthcare budgets.
Right now, the situation in Europe is being exacerbated by the effects of COVID, inflation and increasing energy costs, meaning our health systems will only come under further financial pressure. In October 2022, for example, the Chief Financial Officer of NHS England, Julian Kelly, reported an unexpected financial shortfall of £6-7 billion.12
Increasing the use of biosimilars can help relieve this pressure, but their full benefits will not be realized without maximizing their potential through improving access and driving competition.
The promise of biosimilars
There’s growing evidence that biosimilars support more sustainable healthcare systems by expanding patient access to highly efficient, safe and affordable biologics.
These four case studies illustrate the value that adoption of biosimilars can deliver for patients, healthcare professionals, healthcare systems and regulators around the globe:
UK (EU): value for regulators
In 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published updated guidance on its licensing pathway for biosimilars so that it will no longer routinely require comparative efficacy and safety data (large Phase III trials).
This streamlined development process means that regulators will be able to introduce competition at a faster rate, meaning patients in the UK will be able access these potentially life-changing medicines sooner. 13
New Zealand: value for patients
The change in funding of a biosimilar brand and approval for its use by Medsafe (the New Zealand Medicines and Medical Devices Safety Authority) is enabling more individuals with cancers and inflammatory conditions to be treated each year and freeing up a limited budget to fund other medicines.14
United States (US): value for healthcare systems
In 2021, biosimilars generated $7 billion in savings for patients and the healthcare system. Since the first biosimilar was approved in the US in 2015, biosimilar medicines have generated more than $13 billion in savings.15 In oncology, biosimilars have cut the growth rate in spending for medications almost in half.15
Biosimilars have increased lifesaving treatment options for patients. To date, biosimilars have been used in 364 million days of patient therapy and supported 150 million incremental days of therapy that patients would otherwise not have received without biosimilar competition.15
Germany: value for healthcare professionals
Biosimilars introduce competition, and increase the affordability of biologics, which ultimately delivers savings and value-added services to support patient care and the healthcare community. This means HCPs have been able to treat more patients with high-quality biologics while reducing spend.
For example, in Germany, the number of daily therapy doses of an anti-TNF medicine, increased by 29% (from 17.18 to 22.18 million) after the introduction of biosimilars.16
Unlocking the potential of biosimilars
The Pharmaceutical Strategy for Europe, adopted in 2020 by the European Commission, looks to ensure, among other things, access to affordable medicines for patients and to support competitiveness, innovation, and sustainability across the EU’s pharmaceutical industry.17
The arrival of biosimilars has given more patients access to effective therapies while also reducing the cost of medicines for healthcare systems.
In 2020 alone the adoption of biosimilars saved the EU €5.7 billion.18
However, there are challenges, including gaps in biosimilar adoption (some countries have much higher adoption rates than others) and counter-intuitive incentives in the US healthcare market, for example, that favour higher-cost medicines over lower-cost biosimilars.15
In the US, biologic medicines represent just 2% of pharma prescriptions by volume, but 37% of the total cost.19
To smooth the pathway for the continued adoption of biosimilars when a biologic loses its exclusivity, efforts need to be focused on ensuring the long-term market sustainability for biosimilars, the education of healthcare professionals, and streamlining the development of biosimilars.
Ensuring long-term market sustainability: The biosimilar market needs to be sustainable to ensure healthy competition; competition keeps the market innovating, whereas a lack of competition focuses on driving down production costs, higher profits and no value-added extras to improve patient care.
Streamlining biosimilar development: Streamlining comparative efficacy trials and bringing more consistency to regulatory requirements at the global level will help increase uptake of biosimilars.
Improving healthcare professional (HCP) and patient education: Improving education around the safety and efficacy of biosimilars, especially in new therapy areas, as well as enhancing patient and HCP understanding of the important role played by biosimilars as well as their broader potential for transforming global access to the latest treatments.
Not only is all of the above achievable, but it could also help change the lives of millions of patients across the world by ultimately improving healthcare access. A huge amount of progress has been made but working together with multiple stakeholders is needed to unlock biosimilar potential!
Driving Action: Sandoz has founded and sponsored Act4Biosimilars. Led by a multidisciplinary Steering Committee, this global initiative is driving action to improve access to biologics by increasing the global adoption of biosimilars by at least 30% in 30+ countries by 2030.