The European Union (EU) has established a leading role in biosimilar regulation since 2006, with approvals spanning multiple drug classes and indications, including monoclonal antibodies and recombinant hormones. In 2022, the European Medicines Agency (EMA) announced that biosimilars approved in the EU are interchangeable with their reference products, facilitating their integration into healthcare systems. In this blog, we will uncover the impact of biosimilar policies on biosimilar pricing and uptake across five major markets – Germany, France, Italy, Spain and the United Kingdom (EU4 + UK).
The Increasing Importance of Biosimilars
Between January 2019 and May 2024, 17 biosimilars were launched in the EU4 + UK, including Yesafili for retinal vascular diseases and Yuflyma for inflammatory conditions. The anticipated loss of exclusivity for the PD-(L)1 inhibitor Keytruda in 2031, a product responsible for over half of global PD-(L)1 sales, highlights the growing potential for biosimilars to expand within oncology. However, evolving biosimilar policies across Europe will continue to shape pricing dynamics and market access strategies.
Variations in Pricing Policies Across EU4 + UK Markets
Biosimilar pricing policies (Table 1) vary significantly across the EU4 + UK, reflecting the distinct regulatory priorities of each market. Markets with regulated pricing policies and hospital-level tendering, France, Italy, and Spain aim to ensure affordability and market stability. In France, biosimilars prices are set at 40% below the originator, with tenders conducted at national, regional and hospital levels, to promote competition while maintaining market sustainability. Italy mandates a 20% discount on originator prices, enforced through national and regional tenders, which contribute to pricing stability and consistent adoption of biosimilars. Similarly, Spain implements price caps for biosimilars at the national, regional and hospital level, while also implementing regional usage quotas to encourage adoption and support healthcare cost containment.
Germany also employs a regulated pricing policy, but it differs in its reliance on retail-level tendering rather than a centralised tendering framework. Biosimilar prices are determined through hospital-level negotiations and influenced by Internal Reference Pricing (IRP) based on the average price of biosimilars. Retail-level competition drives significant price reductions, providing a unique dynamic compared to other regulated policies.
In contrast, the UK operates under an unregulated pricing policy, which sets it apart from the other EU4 countries. While pricing is not fixed, National Health Service (NHS) guidelines establish maximum prices for high-cost biosimilars, such as adalimumab. Regional NHS-led tenders further drive competition by encouraging flexible discounts rather than enforcing fixed pricing, enabling greater market flexibility.
Table 1. Biosimilar pricing policies across the EU4 + UK
Financial Incentives and Their Impact on Biosimilar Uptake
Biosimilar adoption across the EU4 + UK is shaped by a combination of financial incentives (shared savings or gain share agreements and penalties), prescription quotas, price regulation policies, tendering systems, including switching protocols. These policies not only influence prescribing behaviour but also impact market penetration. To illustrate the effectiveness of these incentives, infliximab – a widely adopted biosimilar – serves as an example throughout this analysis, illustrating how each type of incentive impacts biosimilar adoption across countries.
Germany: Gain Share Agreements And Prescription Quotas Drive Biosimilar Adoption
Financial incentives and penalties are crucial drivers of biosimilar uptake. In Germany, initiatives such as the BioLike program promote biosimilar use by sharing savings between physicians and insurers, while financial penalties discourage prescribing higher-cost originator biologics. These measures have contributed to significant adoption rates for biosimilars, including infliximab. Prescription targets and quotas encourage cost-effective treatment options while preserving physician autonomy. In Germany, prescribing quotas are defined annually by the National Association of Statutory Health Insurance Funds (GKV-SV) and the National Association of Statutory Health Insurance Physicians (KBV). The GKV-SV and the KBV guide regional physician associations in setting binding targets. These quotas, which vary by federal state, have contributed to significant biosimilar penetration, with infliximab achieving an 87% market share in some regions.
United Kingdom: Gain Share Agreements and Non-binding Prescription Quotas Drive Biosimilar Adoption
In the UK, non-binding prescribing quotas, outlined in the NHS ‘Commissioning Framework for Biological Medicines’, encourage treatment-naïve patients to initiate therapy with biosimilars. Targets include prescribing the “best-value” biological for 90% of new patients within 3 months of biosimilar launch and converting at least 80% of existing patients within 12 months. For instance, these measures have driven infliximab biosimilar uptake to approximately 89% of the market by sales volume, generating significant savings of £99.4 million in 2017 alone. The UK relies heavily on gain share agreements, reinvesting savings from biosimilar adoption into healthcare systems, creating incentives for hospitals and prescribers.
Italy and Spain: Decentralised Regulated Pricing Policies and Regional Level Prescription Quotas Drive Biosimilar Adoption
Italy and Spain implement regional-level quotas and regulated pricing policies to drive adoption. As of 2021, in Italy, uptake varied significantly across regions, with Piemonte and Toscana achieving infliximab adoption rates above 95%, while regions such as Calabria and Abruzzo reported much lower rates. Regional policies, tendering practices, and prescribing objectives, such as Piemonte’s 95% target, play a key role in driving adoption. In Spain, regional tendering processes and hospital-level switching protocols led to varied uptake, with regions like Asturias and La Rioja showing higher adoption due to proactive policies. While these measures support biosimilar use in both countries, the decentralized implementation makes overall impact tracking more complex.
France: Gain Share Agreements And Hospital-level Initiatives Drive Biosimilar Adoption
Like the UK and Germany, France has adopted gain share agreements through targeted programmes such as the Payment for Performance initiative (CAQES) and hospital-based initiatives like the Article 51 Experimentation Programme. These agreements enable hospitals and prescribers to receive 20-30% of the cost savings from prescribing biosimilars, with allocations reinvested into resources, equipment, or staff training. Hospital-level tenders also contribute, with national targets aimed at 80% biosimilar penetration among ambulatory patients by 2022.
Table 2. Adoption of financial incentives for biosimilar uptake across the EU4 + UK
Price Erosion Outcomes Across the EU4 + UK
This analysis highlights how access policies and financial incentives aim to shape biosimilar pricing outcomes and uptake across these five major European markets. The variability in price erosion reflects the interplay among price regulation policies, tendering, financial incentives (including gain share agreements) and prescription targets or quotas.
The UK: Free Pricing Policies Drive Steep Price Erosion
The UK’s NHS-driven centralised tendering system and switching policies resulted in the highest price erosion among the EU4 + UK, with biosimilars averaging a 58% reduction from launch prices (Figure 1). This policy environment encourages competitive pricing while maintaining strong uptake of 68% (Figure 2), with biosimilars accounting for over 70% of treatment days in Q2 2023. The strong uptake of biosimilars in the UK is a result of having free pricing policies; however, this results in greater price erosion, which may deter market entry and reduce competition over time, hence it may raise concerns about the long-term sustainability.
France and Germany: Structured Pricing Policies Balance Sustainability and Uptake
In contrast to the UK, France and Germany show moderate price reductions – 26% and 23% respectively (Figure 1) – reflecting their structured policy approaches. For instance, France’s reference pricing policy ensures consistent cost management, while Germany relies on physician discretion in prescribing and switching. These frameworks support biosimilar uptake rates of 59% to 65% (Figure 2), demonstrating a balance between affordability and market penetration. These structured approaches ensure long-term market sustainability while achieving competitive uptake levels.
Italy and Spain: Regulated Pricing Policies Prioritise Stability
In Italy and Spain, regulated pricing policies, including fixed discounts of 20-40% below originator prices and regional tendering, limit price erosion to 10% and 11% (Figure 1), respectively. While these policies ensure market stability, they correlate with modest/negative biosimilar uptake amounting to 63% for Spain and 71% for Italy (Figure 2) – indicating that regulated price policies, while limiting price erosion and maintaining market stability, can reduce market competition. This may lead to slow/uneven adoption of biosimilars across regions, demonstrating how controlled policies can balance affordability with sustainable adoption, albeit at the potential cost of broader market competition.
Figure 1. Biosimilar price erosion across EU4 + UK
Figure 2. Correlation between price erosion and biosimilar uptake across the EU4 + UK
Conclusion
Access policies play a pivotal role in shaping biosimilar pricing and uptake across Europe. This analysis highlights how differences in price regulation policies, tendering, financial incentives, and prescription targets or quotas result in distinct levels of price erosion and biosimilar uptake in the EU4 + UK markets.
- Free pricing policies, such as those in the UK, are characterized by greater flexibility in price-setting and NHS-driven competitive tendering. These policies result in strong uptake but also lead to significant price erosion.
- Regulated pricing policies in Italy and Spain include fixed discounts and multi-level tendering, which ensure market stability while maintaining modest/negative uptake levels.
- Structured pricing policies in France and Germany strike a balance between affordability and market sustainability. France achieves moderate price reductions through reference pricing and tendering, while Germany relies on regional quotas and physician discretion, delivering controlled price reductions alongside steady biosimilar uptake.
These variations demonstrate the importance of aligning market access strategies with specific policy environments. Understanding how access policies influence biosimilar dynamics is essential for optimizing both pricing and adoption across diverse markets.
Download our abstract and full podium presentation presented by Vishal Yadav during ISPOR Europe 2024, in Barcelona, Spain, to gain deeper insights into these critical market access challenges and opportunities.