Biosimilar Uptake Policies Work Only as a Mix, Observatory Says

Biosimilar medicines are off-patent copies of biological medicines that contain the same active substance. They cost health systems less than the originator products. Europe approves more of them than any other region. The European Medicines Agency has adjusted its biosimilar approval framework. Yet the European Observatory on Health Systems and Policies opened its 6 October 2026 webinar on biosimilar uptake policies with a blunt point: having a biosimilar on the market is not the same as getting it to patients.

Uptake differs sharply from one country to the next, from region to region within countries, from one therapeutic group to another, and between hospital and outpatient care. The Observatory used the session to present Policy Brief 76, “How can countries harness the potential of biosimilar medicines? A toolkit for policy-makers”, and to hand the floor to four people who have run the policies it describes.

Sabine Vogler, who directs the WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies at Austria’s national public health institute, delivered the keynote. She was one of the brief’s authors, and she started by lowering expectations.

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“I’d love to say that we have a ready solution, but as you can well imagine this is of course not the case. In the area of biosimilars there are several levers and enablers that we can use and we can make a difference.”

The toolbox: supply-side measures, demand-side measures and the design of each one

Public procurement of medicines is where most European countries act first, and tendering is the most frequently used tool of all. Demand-side measures that target prescribers are common. Gain sharing is rare. Substitution at pharmacy level is newer still, and has been introduced in Norway, France, Switzerland, Finland and, more recently, Denmark.

Design decides whether a measure works, Vogler argued. Tendering is often described as a way to drive prices down, but it can be built to weigh security of supply, to make multi-winner awards, and to run through framework agreements.

“So you see the design is key, and I would like to stress again the policy mix is key. It’s not that you just have one measure, one policy. You shall combine it.”

Several principles sit around the toolbox. Policy-makers need to decide what level of competition they are aiming for before they pick instruments, to think across sectors and settings rather than within one budget line, and to work out which health professionals to involve. Vogler pointed to price link policies and substitution as measures modelled on generics policy, where two to three decades of experience have produced evidence on both acceptance and the awareness-raising that supports it.

Ireland: a €500-per-patient gain share sent savings back to clinics

Bernard Duggan from Ireland’s Health Service Executive described the Best Value Biological Medicine programme, which covers self-administered biological medicines, and in particular the gain share arrangement built for adalimumab and etanercept.

In June 2019, about 97% of Irish patients receiving adalimumab were on the originator product and only about 3% on a biosimilar, even though biosimilars had been available since November 2018. Etanercept looked much the same, more than two years after biosimilars reached the market.

Duggan traced the problem to a budget misalignment. Demand was generated by hospital prescribers, but the budget holder was the central reimbursement agency, because prescriptions were dispensed through community pharmacies and funded centrally.

“There was a lack of incentive for behaviour change at a local level.”

The answer was to return part of the saving to the team that created it. €500 accruing per patient was made available to the clinical team responsible, and payment followed a consultant- or specialist-led decision to start a patient on, or switch a patient to, a best value biological medicine. The money had to be spent on service delivery and clinic improvements.

The national prescribing and ordering platform did the accounting. Because prescriptions were written online, the system could identify which hospitals were switching patients and allocate the gain share to them. Hospitals could see how much they had earned, and drew the funds down through a local form signed off at national level.

What the clinical teams bought with it reads like a list of ordinary service gaps: ultrasound machines, polarized light microscopes, developments to infusion suites, waiting list initiatives to see more patients, extra first-time appointments, and education and training for team members.

By June 2023, more than 80% of patients receiving adalimumab were supplied with a biosimilar, and more than 70% of those on etanercept. Over the four years, more than 25,000 patients were prescribed a biosimilar for the two medicines. A gain share fund of €10 million went back to clinical teams, against overall savings in excess of €100 million.

Spain: a draft law on dynamic pricing, held up by an early election

Jaime Espín, a professor at the Andalusian School of Public Health, has worked on this topic for a long time. He co-authored the first biosimilar report the European Commission published, in 2011, with Joan Rovira.

A 2019 public expenditure review found that Spain’s biosimilar penetration sat below the European average for three of the six active substances where data were available. Hospital uptake of about 80% was roughly in line with the European average. Community pharmacy, at about 45%, was the weak point, though that segment is dominated by insulins and similar products.

Pharmaceutical policy in Spain sits largely with the regions, and the review found wide differences between them in both community and hospital settings.

The country’s pharmaceutical strategic plan for 2024 to 2028 carries a commitment to encourage the use of off-patent medicines including biosimilars. A draft medicines bill would keep prescribing by brand name, introduce a dynamic pricing system for generics and biosimilars under article 121 in which price moves with volume, and set up an observatory of generic and biosimilar market share. Espín pointed to Portugal’s biosimilars observatory, which publishes uptake by active substance, as the model.

Then came the news that stopped it.

“So this new bill is not going to be approved, because we have an election, and we need to wait to see what happens.”

Espín also returned to a communication gap that has survived two decades of biosimilar policy.

“Still there are many people that do not know what a biosimilar is, and people confuse biosimilars. It should be a really strong recommendation to have a campaign explaining that a biosimilar is similar to the originator.”

Biosimilar uptake policies: trust, stakeholders and the evidence problem

The session turned to questions from the audience, relayed by co-moderator Erica Richardson. Were patients involved as stakeholders, and did the financial incentives bother them? What made the Irish model work? What gets stakeholders on board when they do not gain financially, as with pharmacists? How do you guide physicians towards prescribing biosimilars?

Duggan put stakeholder engagement first. His team designed the gain share with the clinical teams, asked what would and would not work, and kept the process simple because the prescribing platform already existed.

“We engaged prior to doing it. We listened to the potential concerns and we put in place processes that were aligned with our national governance in relation to use of funds, and then the local issues that potentially could have arose. We tried to address that.”

Vogler said some prescriber concerns turn out not to be about biosimilars at all. Understanding how people work inside their organisation matters more than restating the science. She also made the case for looking past the savings figure.

“It’s not just the savings. I think uptake and, a little bit more difficult to generate, finding out with other studies the acceptance: have prescribers, have pharmacists and particularly patients changed, what’s their level of understanding?”

Who delivers the reassurance matters too. Vogler cited a 2022 statement on interchangeability from medicines regulators, and the role of peers: prescribers listening to other prescribers, and patients listening to people who speak their language.

Espín raised a constraint that sits outside pharmaceutical policy. Gain sharing makes sense in principle, but several countries have legal barriers that stop them paying doctors a share of the savings they generate. He also expected more competition to arrive as the regulatory framework changes, noting that head-to-head clinical trials currently limit how many biosimilars reach a single product.

His closing point was about what the numbers are for.

“A few years ago I went to Romania and someone told me: don’t speak about saving. Tell me how many patients have access right now to biological medicine, to the biosimilar. I think this is probably more important than saving.”

Source: European Observatory on Health Systems and Policies webinar, “How can countries harness the potential of biosimilar medicines?”, 6 October 2026, and Policy Brief 76: How can countries harness the potential of biosimilar medicines? A toolkit for policy-makers.