Solving the Biosimilars Void in Europe
Creating a Sustainable Access Environment for the Future
Adam Levysohn, Vice President and Head of Commercial Strategy Europe, Samsung Bioepis
Biosimilars enhance European healthcare with €56 billion in savings, broader patient access, and supply security. Challenges like restrictive policies and price erosion risk create a "biosimilar void". The article suggests tailored approaches to post-launch pathways that are crucial for sustaining biosimilar innovation, expanding access, and unlocking their long-term value for healthcare systems.
Biosimilar void: A concept introduced by IQVIA when classes of biologics that are at risk of failing to attract biosimilar competition after LoE.
Since the first biosimilar launch in 2006, biosimilars have become an important part of the European healthcare system: In the last decade (2013-2024), the cumulative clinical experience with biosimilar medicines exceeds 6.9 billion patient treatment days and biosimilars have delivered €56 billion in cumulative savings across Europe.
Biosimilar competition is integral to creating stronger and more resilient healthcare systems
Biosimilars are an integral part of the healthcare system and form the ‘virtuous cycle’ of competition and innovation, as cost savings from biosimilars allow redistribution of healthcare budgets to improve quality of care and create headroom to invest in next-generation innovative medicines. Generally speaking, biosimilars help patients get broader and earlier access to biologics. When patients do not have timely access to appropriate treatments, it can significantly impact their disease progression. However, the introduction of biosimilars can lead to higher utilization of the molecule as lower costs bring more patients within the window for feasible treatment. In addition, biosimilars help improve supply chain resilience and mitigate supply risks by diversification of suppliers for biologic medicines. These are all critical value elements for European markets facing budgetary pressures for pharmaceutical spending, increasing delays in patient access and escalating challenges with supply security as highlighted in multiple EU-level and national policy agendas. And the financial pressure on healthcare systems is only set to grow with the ageing population and increasing disease burden.
Is the policy environment in Europe sustainable for biosimilars?
However, the current policy environment in Europe, particularly the post-launch pathways, are not yet most optimal to recognize the value of biosimilars and ultimately support a more sustainable market. Health technology assessment (HTA) and pricing & reimbursement (P&R) processes are generally well-established for novel biologics, but they are not streamlined or appropriately tailored for biosimilar value assessment. These challenges are further exacerbated by winner-takes-all tendering and cost-containment policies that lead to continuous price erosion throughout the biosimilars lifecycle. Finally, lack of awareness and understanding of biosimilars hinder sufficient uptake of biosimilars, thereby limiting the potential value that can be realized.
With high development costs and growing competition, we are seeing less and less biosimilar manufacturers maintaining their participation in the market. In the coming years, many biologics facing loss of exclusivity (LoE) do not have biosimilars in development, an outcome called the "biosimilar void." Looking solely at the savings generated from biosimilar competition, European markets stand to lose a minimum of €15 billion of savings as a result of the biosimilar void, approximately 25% of the total LoE opportunity by 2032. With 110 biological medicines anticipated to lose exclusivity in Europe by 2032, almost 27% of 26 high-sale products do not yet have a biosimilar candidate in the pipeline, which represents up to €8 billion in missed opportunity for cost savings.
Recommended policy changes for a sustainable biosimilar market
For healthcare systems to continue benefiting from biosimilars and improving patient outcomes, thoughtful policy reform is required to create a sustainable biosimilar environment, where the business of developing and supplying high-quality biosimilars is appropriately supported. By establishing policies that facilitate collaboration and mutual understanding among stakeholders, healthcare systems can unlock the full value of biosimilars, both now and in the future. To achieve this, optimizing key areas will be instrumental in driving progress and ensuring long-term success for all involved:
1. Simplify and tailor HTA processes to support timely and value-based decisions: health technology assessment processes can provide important guidance for pricing and reimbursement decisions, but often require significant resources to undertake. This leads to delays in access and imposes a high burden of evidence in traditional practices. HTA processes need to be updated and streamlined to reduce delays of biosimilar entry and fully recognize their holistic value: biosimilars are approved based on solid scientific evidence that demonstrate biosimilarity in terms of mechanism of action, pharmacokinetics, and pharmacodynamics, and the scientific principle of ‘extrapolation’ allows biosimilars to be approved for an indication that is not directly studied in a comparative clinical trial. This same scientific concept can also be applied in post-marketing phase, where biosimilars can be automatically approved for the new indications of the reference biologic, based on the scientific and regulatory principle of ‘extrapolation.’
2. Implement fair biosimilar pricing rules and controls at launch: Oftentimes, healthcare systems set arbitrary price controls at launch, including mandatory and unjustified price discounts. Such controls often fail to account for complex development processes and significant investments required to develop high-quality biosimilars, thereby undervaluing the broader values and fair prices that need to be set for biosimilars. Another proposed measure is introduction of free pricing for biosimilars, whereby price discounts are achieved naturally via market competition between multiple biologics, instead of arbitrary price controls.
3. Provide exemptions for biosimilars from wider cost-containment policies: Existing alongside the already existing fierce price competition, cost-containment mechanisms such as end-of-year clawbacks often disproportionately impact biosimilars by resulting in ‘double’ price erosion. When biosimilars launch in the market, their prices are already discounted significantly compared to reference products and they face heightened downward pricing pressure in the market from cost-containment policies and competition. These combined forces can force biosimilar manufacturers to pull the product off the market, impacting the security of supply of medicines. To create a sustainable biosimilar environment, healthcare systems must recognize the key role biosimilars already play in achieving efficiencies and implement policies that protect biosimilars from excessive and unsustainable price erosion.
4. Update tendering processes to adequately consider biosimilars and support their competition: Winner-takes-all tenders that do not allow for multiple competitors to be on the market poses a significantly adverse effect on the sustainability of the market and also may lead to supply restrictions. Furthermore, sub-national tendering practices can increase price pressures when regional health authorities set a maximum bidding price (base price) for companies submitting to a tender. The contracting process at all levels (including national, regional and local) should be inclusive and consider broader factors in decision making and support competition.
5. Encourage prescription of high-quality biosimilars while preserving stakeholder autonomy: To increase biosimilar uptake, there must be sufficient demand and prescription of biosimilars. Physicians play a pivotal role in this process, and policies that encourage prescription such as benefit-sharing programs are vital. Biosimilars should not be regarded solely as a cost-reduction mechanism, but they should be valued as effective treatment options for patients and as catalysts for continuous innovation in their development. In addition, prescribing and dispensing decision for biosimilars should be guided by shared decision-making to support communication and input from physician, pharmacist and patient to achieve best outcomes.
6. Increase education for key stakeholders to support understanding of biosimilar value: Alongside incentives, willingness to prescribe a biosimilar medicine is strongly tied to the level of understanding of biosimilars. While the European Medicines Agency (EMA) announced that biosimilars could be used interchangeably with reference biologic medicines in 2022, misconception persist among physicians and patients. To combat these concerns, wide-reaching education for all stakeholders is a key to creating a sustainable biosimilar environment.
Ensuring a resilient healthcare system for future generations
It was the introduction of anti-TNF biosimilars from 2014 and onwards that really cemented the holistic value of biosimilars across Europe: simultaneously and fast, patients got broader and earlier access to high-quality biologic treatments, health care providers obtained higher supply certainty, and health care systems realized significant savings as biosimilars became widely available for the treatment of autoimmune diseases. However, the urgent need for cost savings among European health care systems and intense biosimilar competition have led to aggressive price erosions similar to the level of competition and pricing discounts for generic drugs. But the biosimilar market is different from generics: biosimilars are more complex to produce, deliver, and administer, and have higher development costs; hence ‘brand’ development cost and ‘generic’ pricing are not sustainable for biosimilars.
Legacy biotech companies are leaving the biosimilar space and if this trend continues, the consequences will be the loss of cost-saving opportunities for healthcare systems, providers and patients, and biosimilar investments will be narrowed down to only multi-billion-dollar treatments and less on orphan, rare diseases that are smaller in market size. Unless policies are adapted and tailored to integrate biosimilars more effectively into healthcare systems, the ‘biosimilar void’ will become broader and lead to higher risk of supply disruption of medicines and less savings for health care systems, which will ultimately be detrimental to patients. Concerted efforts from different stakeholders and jurisdictions across Europe are needed to streamline and tailor policies that can incentivize the continued development of biosimilars to ensure a resilient, patient-centric healthcare system for future generations.
References:
IQVIA Whitepaper. The Impact of Biosimilar Competition in Europe. January 2025. Available at: https://www.iqvia.com/-/media/iqvia/pdfs/library/white-papers/the-impact-of-biosimilar-competition-in-europe-2024.pdf
ISPOR. When and How to Conduct Health Technology Assessments for Biosimilars? May 13, 2024. Available at: https://www.ispor.org/heor-resources/news-top/news/view/2024/05/13/when-and-how-to-conduct-health-technology-assessments--for-biosimilars
IQVIA. Assessing the Biosimilar Void. October 2023. Available at: https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/assessing-the-biosimilar-void/iqvia-institute-assessing-the-biosimilar-void-10-23-forweb.pdf
The European Medicines Agency. Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU. September 2022. Available at: https://www.ema.europa.eu/en/documents/public-statement/statement-scientific-rationale-supporting-interchangeability-biosimilar-medicines-eu_en.pdf
Author Bio
Adam Levysohn is Vice President and Head of Europe Commercial Strategy at Samsung Bioepis, and serves on the Samsung Bioepis Executive Committee. Adam began his pharmaceutical career at Novo Nordisk, holding market access and commercial leadership positions at both headquarters and in the European Region Office. In 2015, he joined Biogen Biosimilars as a founding member of the BBU leadership team, focusing on global market access, pricing, tender management, and go-to-market strategy. Before joining Samsung Bioepis, Adam served in different leadership positions in the rare disease space.
