Tendering emerged as the most effective strategy for reducing costs and increasing biosimilar uptake in the retail setting, while price-linked discounts and prescribing quotas have shown mixed or uncertain results.
Tendering was the most effective policy for reducing expenditures on anti-tumor necrosis factor (TNF) biosimilars in the retail setting, while price links with low discounts were less effective, and the impact of prescribing quotas remains uncertain, according to a review.
The 13 countries examined for the present study were Australia, Belgium, Canada, UK, France, Norway, Sweden, Switzerland, Spain, Germany, Italy, Japan, and the Republic of Korea. | Image credit: gopixa - stock.adobe.com
The review, published in BioDrugs, was conducted to evaluate the impact of different biosimilar-promoting policies on the uptake and cost savings of biosimilars, particularly for high-cost anti-TNF biologics, as biosimilars face market entry challenges due to originator company influence, physician hesitation, and procurement barriers despite their potential for significant health care savings.
Researchers investigated biosimilar policies and their impact on market uptake and cost reduction across 13 of the 38 Organisation for Economic Co-operation and Development (OECD) member countries. The literature review included data sourced from PubMed, Google Scholar, and government sources to identify supply-side and demand-side biosimilar policies. Researchers analyzed IQVIA MIDAS sales data (2012-2023) for adalimumab, etanercept, and infliximab, measuring uptake as a percentage of total sales. They calculated price reductions by comparing actual 2023 expenditures with hypothetical costs had biosimilars not been introduced.
To evaluate policy impact, they used a narrative summary approach, selecting five key policies per country and creating country and within-country policy comparison pairs. By comparing uptake and cost reductions in settings that differed by only one policy, they assessed the influence of individual biosimilar policies.
The study conducted a comprehensive review of biosimilar-promoting policies and their impact on the uptake and expenditure reductions for adalimumab, etanercept, and infliximab across 13 OECD countries. The analysis revealed a consistent and significant increase in biosimilar uptake over time for all three originator medications, highlighting the growing acceptance and integration of biosimilars into healthcare systems. However, despite this increase in uptake, expenditure reductions were not universally aligned with higher biosimilar adoption rates, suggesting that uptake alone does not automatically lead to cost savings.
Key insights from the results demonstrate that tendering played a crucial role in facilitating both biosimilar uptake and meaningful expenditure reductions, especially in retail settings.
For example, countries that employed more concentrated tendering saw higher biosimilar uptake rates, with Norway achieving an impressive biosimilar uptake of 99.4% for infliximab compared with 62.4% in Australia, showcasing the potential of tendering policies in driving market penetration.
Conversely, price link policies, which mandate discounts of around −20% to −25% off the originator's price, did not translate into significant savings, indicating that higher uptake does not equate to optimal cost efficiency. Similarly, prescribing quotas, while appearing to help increase biosimilar adoption, did not consistently result in greater expenditure reductions when compared to environments without such quotas.
Tendering is a process where companies compete in race-to-the-bottom pricing in hopes of having their product chosen to be one of, if not the only, products covered by the health plan in charge.2 To manage budgetary pressures, European payers use cost-containment measures like tendering to reduce pharmaceutical spending on off-patent biologics and biosimilars.3 It is commonly used for hospital medicines, including biologics, and follows European Union public procurement rules when applicable.2
Another important takeaway from the study is the difference in impacts between the retail and hospital settings.1 While tendering facilitated greater savings in the retail environment, its effects in hospital contexts were less pronounced, suggesting that procurement strategies may need to be tailored to the specific dynamics of different health care settings.
Ultimately, the findings underscored the complexity of biosimilar market dynamics, revealing that while certain policies like tendering can yield both increased uptake and expenditure reductions, not all policies will have the same effects across varying contexts. This points to the necessity for health care policymakers to carefully consider the interplay of different procurement strategies and their potential outcomes when aiming to maximize the financial benefits of biosimilars in health care systems.
“Further research with more robust methods is needed to identify which policy approach or approaches best support this cost-saving objective the most,” the authors noted.
References
1. Tam ACT, Badesha J, Guh DP, et al. Biosimilar policies and their impact on market penetration of adalimumab, etanercept and infliximab: a policy synthesis and descriptive analysis in 13 OECD countries. BioDrugs. Published online February 25, 2025. doi:10.1007/s40259-025-00709-1
2. Barbier L, Simoens S, Soontjens C, Clause B, Vulto AG, Huys I. Off-patent biologicals and biosimilars tendering in Europe—a proposal towards more sustainable practices. Pharmaceuticals (Basel). 2021;14(6):499. doi:10.3390/ph14060499
3. Vogler S., Gombocz M., Zimmermann N. Tendering for off-patent outpatient medicines: lessons learned from experiences in Belgium, Denmark and the Netherlands. J Pharm. Health Serv. Res. 2017;8:147-158. doi:10.1111/jphs.12180
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