National Tendering, Combined Policies Linked to Highest Biosimilar Uptake

Eight OECD countries, six biosimilar molecules, and one clear pattern: the health systems squeezing the most savings out of biosimilars are the ones stacking several policies on top of each other instead of picking just one, according to a review published in Pharmaceutical Medicine.¹

An 8-country OECD analysis found the highest biosimilar uptake occurred where policymakers combined multiple supply- and demand-side measures or ran coordinated national tendering. | Image credit: C Malambo:peopleimages.com - stock.adobe.com

Explaining Why Biosimilar Uptake Still Diverges

Biosimilars are approved under comparable scientific standards nearly everywhere they reach the market, yet how quickly, and how fully, health systems actually use them still varies enormously by country. Policymakers have experimented with a patchwork of levers, from price controls to prescriber education to procurement rules, but evidence tying specific combinations of those levers to measurable uptake has remained thin.

The investigators turned to Actor Network Theory, a framework originally developed in sociology, to map how policymakers in each country aligned prescribers, pharmacists, payers, and patients behind a given biosimilar strategy, rather than treating each policy as if it worked in isolation.

To test that idea, the review drew on literature published between 2017 and 2025 covering Australia, Belgium, Canada, Denmark, France, Germany, Italy, and the UK. Each country's supply-side and demand-side policies were classified separately, and biosimilar uptake was measured as the maximum market share reached by biosimilars of 6 reference molecules: infliximab, etanercept, and adalimumab, used mainly in the retail setting for inflammatory disease, and trastuzumab, bevacizumab, and rituximab, used mainly in hospital-administered oncology regimens. Golimumab was excluded because no biosimilar had reached the market in any of the 8 countries compared.

What Separated High, Moderate, and Low Performers

Countries with the highest biosimilar uptake either combined multiple supply- and demand-side measures or ran coordinated national tendering that spanned both hospital and retail markets. Moderate performers applied similar types of measures, but less consistently or with weaker coordination between actors. Countries with the lowest uptake relied mainly on price controls alone, with limited effort to engage prescribers, pharmacists, or patients directly.

Denmark complicates the simple takeaway that more policies are always better: it posted the highest biosimilar uptake of the 8 countries studied by relying almost entirely on broad hospital-and-retail tendering through its centralized Amgros system and a strong clinical governance model, without offering direct financial incentives to clinicians. Within the anti-tumor necrosis factor class specifically, biosimilar uptake exceeded 70% in Denmark, Germany, and Italy, compared with roughly 40% in Australia, where the review found a narrower reliance on price controls and limited incentives for either patients or prescribers.

The researchers reported a correlation between countries achieving high uptake and their reliance on these combined or coordinated approaches, rather than any single policy acting alone. That pattern held across both the anti-tumor necrosis factor and oncology molecule groups, despite their very different prescribing and dispensing settings. As a literature-based analysis spanning 8 countries over an 8-year publication window, the review's conclusions are necessarily shaped by which national policies happened to be studied and published in English-language sources during that period, and may not generalize to health systems with very different payer structures.

The US was not among the 8 countries studied, and its absence is itself instructive. Many of the demand-side levers that the highest-uptake countries relied on, including coordinated national tendering, are easier to execute in single-payer or centrally negotiated systems than in the US' fragmented mix of commercial plans, pharmacy benefit managers, and provider-administered buy-and-bill arrangements. The FDA has spent several years clearing a separate path toward uptake, designating certain biosimilars interchangeable so pharmacists can substitute them without new prescriber approval.² But interchangeability alone does not replicate the tendering, prescribing quotas, or gain-sharing arrangements that aligned every actor in the supply chain behind biosimilar use in the countries this review ranked highest, suggesting US payers may need to look beyond approval-pathway policy if they want comparable uptake.¹

References

1. Rieger C, Dean JA, Merlo G, Hall L. Application of actor network theory to evaluate supply and demand strategies used to encourage international biosimilar uptake. Pharm Med. 2026;40(6):441-455. doi:10.1007/s40290-026-00627-9

2. Statement from Acting FDA Commissioner Ned Sharpless, MD, on policy advancements to help bring interchangeable biosimilars to market. FDA. Accessed October 2026. https://www.fda.gov/news-events/press-announcements/statement-acting-fda-commissioner-ned-sharpless-md-policy-advancements-help-bring-interchangeable