15 years of biosimilar access in Europe

COVID-19 has sent a shockwave through global healthcare systems, exposing the fragility built up over decades of increased demand and pricing pressure, and exacerbating the financial pressures on healthcare providers. While we have seen amazing work, with record time development of and approvals for vaccines, the pandemic has challenged us to consider how we address the urgent and long-term challenges ahead, particularly around providing more sustainable solutions to drive access to medicines.

Acute pressures on healthcare systems existed well before the pandemic, in large part due to rising patient demand and increased spending on biologics, therapies derived from complex living organisms. In 2018, according to data from the IQVIA Institute, biologics represented 2.2% of all US prescriptions, but more than one third of net drug spending.¹

These medications are one of modern medicine’s most far-reaching achievements. From cancer and colitis to rheumatoid arthritis, biologics have transformed many severe diseases into treatable or even curable conditions for millions of people. Looking ahead, there will be a growing number of biologic medicines approved. This is not a new trend, according to Evaluate Pharma, annual worldwide sales from the top 100 biologics are expected to increase from $88 billion in 2010 to $178 billion in 2024. In contrast, the top 100 small molecules are projected to grow by $5 billion in the same time frame, from $174 billion to $179 billion.²

Therefore, to address rising healthcare costs, we need to make biologics more affordable and widely accessible. Biosimilars – high quality, more affordable versions that match the safety, quality and efficacy of their reference biologic – are an essential way to do this.

Fifteen years ago, in April 2006, Sandoz received marketing authorisation from the European Commission for the world’s first biosimilar. Here, I look back at where biosimilars have already succeeded and suggest actions that could further accelerate their adoption to help patients and healthcare systems.

Europe leads the way

Biosimilars are now available in 100-plus countries and have generated more than two billion patient days of treatment in Europe alone.³ Europe has led the way, approving more treatments than any other place on the globe. In Europe, biosimilars have now captured 10% of the total biologics market value, most of that (7%) in the past five years. By volume, the amount is substantially higher, reflecting the steadily increasing level of savings due to growing biosimilar competition and penetration.⁴

Today, more than 60 biosimilars have been approved for use in the European Union, with several others currently under evaluation. This is due to the leading efforts of the European Commission with the European Medicines Agency to develop a full policy and legal framework for the approval of biosimilars and provide the appropriate support to bring these products to patients.

At a national level, governments and purchasers have created incentives as well as diverse reimbursement and procurement policies to expand competition and biosimilar uptake. The results have often been striking; with each new launch, we have seen an acceleration of uptake. In Denmark, for example, uptake rates for biosimilar versions of some biologics treating immunologic diseases ranged from 85% to 97% of the market share within one year of market entry.⁵ In Germany, biosimilars now capture between 27% and 89% of the market share, varying by region and molecule. We have also seen a great example of increased patient access in Germany where the waiting time for patients with rheumatoid arthritis to be treated with a biologic has been reduced from 7.4 years to 0.3 years after the introduction of biosimilars.

However, the European experience cannot be seen as a universal success story: despite being the largest biosimilar market globally, there is 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.

Many more biologics will lose their exclusivity in the next few years, further growing the potential market for and impact of biosimilars on patients and healthcare systems. Between 2019 and 2023, it is estimated that this new wave of biosimilars could save healthcare systems $160 billion globally.⁶

However, while significant progress has been made, the job is far from done. In order to ensure that patients and healthcare systems can experience the benefits that biosimilar medicines provide, it is important to take action now to create a sustainable framework for biosimilar adoption. There are several ways in which regulators, policymakers and national authorities can work together to address current barriers and encourage acceptance and uptake. These include:

Addressing inequalities in access to biologics

Access to innovative biologics varies significantly from country to country across Europe. Closing this gap lies at the heart of European policymaking, as seen in the European Pharmaceutical Strategy and Beating Cancer Plan. In countries with low pre-existing access to biologics, such as in Central and Eastern Europe, many different elements must come together, including:

* Strengthening the capabilities to diagnose and put patients on treatment (ie, through clinical guidelines and clinical education)

* Developing policies, which focus on prevention, early detection and faster diagnosis to support better treatment outcomes

* Enhancing awareness amongst physicians, purchasers and policymakers, to understand the important role played by biosimilars and the broader potential for transforming global patient access to the latest treatments

* Engaging with policymakers to facilitate the faster entry of biosimilars to the market, particularly by streamlining reimbursement procedures.

Encouraging biosimilar use through incentives

* Adoption of gain-sharing models, where part of the savings from using biosimilars goes to the hospital, hospital department or prescribing physician, can be a meaningful solution to increase biosimilar uptake. France has developed very interesting models along these lines

* Switching programmes, under the guidance of the treating physician, can also be supported by pharmaceutical companies through providing supportive infrastructure to monitor patients and gather medical evidence.

Developing smart, innovative and sustainable procurement

* There is currently significant variation in how European countries procure medicines and negotiate prices, leading to wide variations in adoption of biosimilars

* There should be a movement away from the current cost-driven ‘winner takes all’ approach. Instead, there should be alignment on incentives and infrastructures that focus on long-term value, sustainability, and healthy competition. For example, countries could agree to open tenders as soon as competition enters the market, as in Italy.

As we look at the healthcare landscape beyond COVID-19, the opportunity to leverage biosimilars as an obvious and sustainable way to increase patient access to medicines has never been closer, and more urgent. In order to build on the success of the biosimilars market to date and promote long-term sustainability, we should take the learnings from the past 15 years and make changes that help to deliver a better future for patients and healthcare systems alike.

I feel privileged to have helped pioneer this highly innovative and exciting area of treatment. And I am looking forward to playing a role in further unlocking the potential of biosimilars as we prepare for the next wave of these important medicines. 

Rebecca Guntern is Head of Region Europe at Sandoz

References

1. IQVIA, Medicines Use and Spending in the U.S. (2019). Available at: https://www.iqvia.com/insights/the-iqvia-institute/reports/medicine-use-and-spending-in-the-us-a-review-of-2018-and-outlook-to-2023.Last accessed April 2021.