The emergence of biopharmaceutical drugs, also known as biologics, has revolutionized treatment for patients with severe conditions in various areas such as immunology, ophthalmology, and oncology. These drugs have contributed to an increase in life expectancy and better health outcomes. However, their high costs make them challenging to access for many patients, especially in regions with constrained healthcare budgets.
Access to biologics in Europe varies widely, with patients in some countries waiting up to 899 days to access new medicines. This situation highlights the need for an alternative approach to improving patient access to these drugs.
Biosimilar medicines offer a solution, as they are biological medicines that are highly similar to already approved biological medicine. Biosimilars have the potential to reduce overall medicine expenditure and improve affordability for patients.
The COVID-19 pandemic has further emphasized the need to develop a sustainable and affordable healthcare system that can withstand future challenges. With the reinforced cooperation in healthcare in Europe, there is an opportunity to foster major change and develop a truly European health policy. Strengthening cross-border healthcare is critical in ensuring equal access to innovation in all Member States.
MEP Tomislav Sokol is an MEP from Croatia and sits in the EPP Group. He is a member of the Committee on the Internal Market and Consumer Protection and the Special Committee on the COVID-19 pandemic: lessons learned and recommendations for the future. He is a substitute member of the Committee on the Environment, Public Health and Food Safety.
Despite the potential of biosimilars, the market for these drugs still needs more development. Biologics currently represent 35% of medicine spending at list prices, and the annual spending on biologics in Europe is €9 billion. To address this challenge, the European Health Union initiative provides a unique opportunity to create a favourable environment for biosimilars by leveraging the revision of the EU general pharmaceutical legislation.
The newly established European Parliament’s SANT committee can open up the debate on these issues and ensure that Europe stays at the forefront of innovation. Streamlining and simplifying the procedures of the European Medicines Agency can accelerate the adoption of biosimilars. The European Commission has the opportunity to update the regulatory framework and focus on introducing structural changes to increase the uptake of biologics and biosimilars.
The European Commission has the opportunity to update the regulatory framework and focus on introducing structural changes to increase the uptake of biologics and biosimilars.
MEP Tomislav Sokol
Ultimately, different stakeholders need to work together to ensure increased affordability and equal access to patients in Europe. Biosimilars can help achieve this goal by providing a sustainable option to reduce overall medicine expenditure, invest in innovation, and improve affordability for patients. By leveraging the European Health Union initiative, we can create a favourable environment for biosimilars and develop a truly European health policy that can address the challenges of the future.
In conversation with... Dan Cohen
Dan Cohen is the Vice President and Head of the Biosimilars Unit for Europe, Canada and partner markets at Biogen. He believes that biosimilar medicines have the potential to increase patient access to biologic therapies and support the sustainability of our healthcare systems.
Healthcare budgets are exposed to increased pressure whilst there is a need for equitable access to innovation for patients. What role can biosimilars play?
Europe is at the forefront of the biosimilar opportunity, demonstrating the ability to transform more lives, reduce healthcare costs, increase patient access and deliver sustainable value.
Ensuring the sustainability of biosimilar competition in Europe is an important success factor for healthcare systems pre- and post-COVID-19. As of 2022, the cumulative savings from the impact of biosimilar competition in Europe reached billions. We are proud at Biogen to have partnered with healthcare systems across Europe; in 2021, Biogen alone generated an estimated €2.6 billion in European healthcare savings.
We believe that biosimilars are central to safeguarding future healthcare innovation. Their increased uptake can alleviate the burden on healthcare systems by offering cost savings and promoting earlier and sustainable access to therapies. For example, prescription of anti-tumour necrosis factor (aTNF) biologic therapy increased by 11% per year since the introduction of biosimilars in Europe.
Can you tell us more about the benefits that biosimilars brought to patients and Europe’s healthcare systems? How come the potential of biosimilars is not yet fully realized?
As a more cost-effective treatment option than their reference biologics, biosimilars have proven to enable for more patients to be treated, while delivering savings that can be channeled into innovation and additional services. However, there are a number of critical hurdles that limit sustainability, including procurement policy, mandated price reductions and government clawback schemes, to name a few. Further advocacy and effective prescriber incentives and support are required. Payers and providers should promote alignment on common objectives across stakeholders, while driving the adoption of sustainable approaches to support biosimilar use.
Physician and patient choice of which treatment option is best for a specific situation must remain. The long-term sustainability of the system may be at risk if the physician-patient choice is removed, and schemes such as automatic pharmacy substitution would undoubtedly have a negative impact.
As a more cost-effective treatment option than their reference biologics, biosimilars have proven to enable for more patients to be treated, while delivering savings that can be channeled into innovation and additional services.
Dan Cohen, Biogen.
The revision of the General Pharmaceutical Legislation is on everyone’s mind these days. Will the commitment to sustainable healthcare systems make a difference for biosimilars? And what could policymakers do to help maximise the benefits of biosimilars?
Biosimilars are an important component of the European healthcare system and present a good way to balance spending by generating savings for payers, creating headroom for innovation, and expanding access to biologic therapy for patients. Enhancing patient access to biosimilars across Europe, while maintaining financial sustainability of healthcare systems, should therefore be an important component of the revision of the General Pharmaceutical Legislation.
At Biogen, we support policies tailored to stimulate biosimilar competition. Policymakers and payers should ensure that pricing dynamics are led by competition, instead of mandatory price decreases.
Finally, awareness and education are the foundation for all policies: all stakeholders should publicly advocate the benefits achieved, such as the number of additional patients treated, new equipment purchased, funding for additional staff, or the scale of overall savings to be reinvested.
This content was commissioned by Biogen.
Biogen-288577 May 2023