White Paper Offers Tips for Sustaining Biosimilar Progress, Avoiding a Market Void

Key Recommendations From the White Paper

Supporting a Competitive Market Entry:
- Introducing free pricing at launch when reference medicines are available, allowing biosimilars to compete on fair market terms without arbitrary initial price restrictions.
- Decoupling price erosion mechanisms such as mandatory discounts or clawbacks that disproportionately impact biosimilars, thus protecting their market value and incentivizing manufacturers to participate.
Enhancing Procurement and Tendering Processes:
- Implementing multi-winner tenders with contract volume shares to diversify supply sources and foster healthy competition over the product lifecycle.
- Designing tender frameworks that consider additional value criteria such as device convenience and supply robustness, encouraging manufacturers to innovate and invest.
Aligning Pricing and Reimbursement Policies with Value:
- Linking biosimilar pricing decisions to comprehensive health technology assessments (HTAs) that reflect their true value, particularly in markets where reference biologics lack prior HTA evaluations.
- Exempting biosimilars from strict cost-containment measures like automatic price cuts or rebates during their lifecycle, thus providing stability and incentivizing sustained manufacturing interest.
Fostering Policy and Market Environment Adaptability:
- Establishing minimum price boundaries that shield biosimilars from excessive price erosion, ensuring adequate margins for manufacturers.
- Promoting collaborative frameworks across Europe for harmonized policies that value biosimilars appropriately, reduce fragmentation, and provide long-term market clarity.

Biosimilars have delivered substantial cost savings and broadened patient access across Europe. However, stakeholders now face the growing risk of a “biosimilar void”—a scenario in which 90% of the biologics losing exclusivity in the next 10 years lack biosimilars in development.¹

Authors of a recent white paper from Samsung Bioepis called for urgent policy reform and industry collaboration to protect the long-term sustainability of the biosimilar market.²

Despite their proven efficacy and safety, biosimilars continue to face skepticism among both prescribers and patients. According to the paper, in Spain, limited adoption has been linked to physicians’ reluctance to switch patients from reference biologics.¹ Additionally, in France, patient hesitation—often influenced by the nocebo effect—stems from poor understanding of biosimilars.

To address these barriers, the report recommended targeted education and awareness initiatives led by trusted medical authorities. Enhancing understanding of biosimilars’ clinical value can help build confidence and support informed decision-making.

“Biosimilars are not one-size-fits-all, and establishing a sustainable framework for biosimilars requires a nuanced understanding of their heterogeneous applications across clinical settings. It is vital to tailor key solutions that address the unique challenges faced by different product types, prescribing patterns, and patient and disease characteristics. It is also important to consider the future viability of the market when reshaping policies, as the market needs clear signals of long-term sustainability to encourage continued investments in the biosimilar pipeline,” said Adam Levysohn, vice president and head of commercial strategy Europe, at Samsung Bioepis.³

Rethinking Pricing and Market Entry Policies

The report warned that current pricing and reimbursement policies often undermine biosimilar sustainability.¹ Mandated price cuts at launch and rigid reimbursement rules can distort competition and deter investment. Instead, the authors advocated for more flexible, market-based pricing models that allow biosimilars to compete on value rather than cost alone.

Reforming health technology assessment (HTA) processes was another priority. Streamlining approval pathways and harmonizing timelines across the European Union could accelerate access and support fair competition. Germany’s approach—exempting biosimilars from certain HTA steps—has been cited as a successful example, leading to faster market entry and stronger uptake.

Investment in monitoring infrastructure will also be key. Real-world data on biosimilar use can inform tailored outreach efforts and support updated clinical guidelines, developed in partnership with medical societies and patient advocacy groups. These strategies are essential for shifting perceptions and encouraging greater adoption.

Ensuring Supply Resilience Through Pipeline Expansion

Supply shortages remain a persistent threat, particularly in oncology and other high-need areas. To mitigate this risk, the white paper urges proactive investment in developing biosimilars for biologics nearing patent expiry. Expanding the pipeline ensures that multiple alternatives enter the market, reducing reliance on single-source manufacturers.

A competitive marketplace not only promotes price stability but also enhances resilience during global disruptions. Encouraging multiple manufacturers to participate in the same therapeutic area strengthens supply security and improves patient access.

While biosimilars are often viewed through the lens of cost containment, they also present opportunities for innovation. The industry can differentiate products by improving environmental sustainability, enhancing patient convenience, and incorporating new technologies.

These next-generation biosimilars—offering features such as easier administration or better packaging—can add value for patients and providers alike. Highlighting these advantages may help attract investment and secure supportive policies from payers and regulators.

Moving Forward

To avoid a biosimilar market collapse, coordinated action is needed. Industry and policymakers must work together to revise pricing structures, modernize regulatory frameworks, and foster robust pipeline development. As the white paper noted, “A biosimilar market with multiple marketed alternatives could play a significant role in increasing supply security and reducing shortages.”

By addressing these structural challenges now, European countries can preserve the economic and clinical benefits of biosimilars, ensuring long-term sustainability for health systems and better outcomes for patients.

Lavysohn commented, “It is important for healthcare systems to recognize that biosimilars are not merely a cost-saving tool for organizations. Policies should take a patient-centric approach, positioning biosimilars as part of the solution to expand access, improve patient outcomes, ensure supply continuity, and strengthen system resilience.”