Rising costs of biologicals: effective cost-containment does not please all stakeholders
Published on 20 October 2025
Generics and Biosimilars Initiative Journal (GaBI Journal). 2025;14(3)
Abstract: |
From the scientific and medical point of view, the biotech industry has developed wonderful medicines for treating chronic and life-threatening diseases. Unfortunately, even wealthy western countries fail to fund the use of current biological medicines sufficiently to meet the demand [1]. Funding new breakthrough products, such as cell- and gene-therapies, will be increasingly difficult. Thus, more efficient cost containment measures are necessary to ensure fair access to important biological medicines.
Biosimilars can reduce the costs of off-patent biologicals, but their full potential has not been exploited in most countries. In this issue of GaBI Journal, Rieger and Holland provide a report of a meeting dealing with the current state of biosimilar uptake in Australia [2].
The Australian Government Department of Health states ‘Biosimilar medicines are used to treat the same diseases, in the same way, as the reference biological medicines. Biosimilar medicines have been tested and shown to be as safe and effective as the reference biological medicines’ [3]. In addition, Regulators of the European Union (EU) [4] and UK [5] have declared that biosimilars licensed in the EU and UK are interchangeable without the need for additional clinical data. Both statements are supported by solid scientific evidence.
Nevertheless. several barriers to biosimilar use were identified in the meeting:
- patients are unwilling to switch to biosimilars due to lack of trust and incentives
- complex instructions of the authorities cause a lot of paperwork from prescribers and pharmacists
- slow adoption of biosimilar medicines by clinicians, biosimilars are often not prescribed to treat naïve patients
- Insufficient support for substitution
Apart from time-consuming paperwork, these problems may stem from the lack of trust due to suspicions of the motives and competence of the authorities who issue instructions [6]. Furthermore, prescribers, pharmacists, and patients have been targets of massive misinformation by the innovative industry over the past 20 years. As a result, lingering concerns over biosimilars remain in their minds.
Many prescribers have a long relationship with innovative industries and their representants. Therefore, they may be reluctant to prescribe copycat products. It is believed that physicians’ autonomy justifies the choice between therapeutically equivalent products without consideration of the costs. Prescribers’ opinions will easily affect the attitudes of pharmacists and patients [2, 7]. In retail pharmacies, substitution causes extra work, such as information of biosimilars and new administration devices. Patients who are using the innovator product may be reluctant to switch unless the prescriber has informed the patient on the benefits of biosimilars and substitution and unless the substitution will lower the out-of-pocket costs.
The view that prescribers, pharmacists, and patients can select the brand of equivalent products that are funded by the government leads to irrational pharmacotherapy. Information and current instructions alone have not been sufficient to overcome the adverse or indifferent attitudes of the stakeholders towards biosimilars and substitution. Australia has a lower uptake of biosimilars compared to the reference countries in the European Union despite of using similar cost containment methods. Therefore, the decision-makers should take bold measures to bypass hesitating prescribers, pharmacists, and patients in selection of the brand of innovator or biosimilar products. Tendering is already successfully applied for hospital drug formularies in Australia but is difficult in the retail pharmacies. Therefore, the substitution in retail pharmacies needs more effective control.
Competing interests: The author declares no conflicts of interest.
Provenance and peer review: Commissioned; internally peer reviewed.
References
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Accessed 29.9 2025.
4. European Medicines Agency. Statement of the scientific rational supporting interchangeability of biosimilar medicines in the EU]. 21 April 2023 [homepage on the Internet]. [cited 2025 Oct 10]. Available from:
https://www.ema.europa.eu/en/documents/public-statement/statement-scientific-rationale-supporting-interchangeability-biosimilar-medicines-eu_en.pdf
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https://www.gov.uk/government/publications/guidance-on-the-licensing-of-biosimilar-products/guidance-on-the-licensing-of-biosimilar-products
6. Lyles A, Heinonen E, Tolonen HM, Linden K, Sihvo S, Sarnola K et al. Current trends in biosimilar uptake and special focus on automatic substitution – a symposium report. Generics and Biosimilars Initiative Journal (GaBI Journal). 2025;14(2). doi: ONLINE FIRST
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Author: Adjunct Professor Pekka Kurki, MD, PhD, University of Helsinki, Lukupolku 19, FI-00680 Helsinki, Finland |
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