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Review
. 2025 Jul;39(4):537-553.
doi: 10.1007/s40259-025-00727-z. Epub 2025 Jun 5.

Beyond Cost: Observations on Clinical and Patient Benefits of Biosimilars in Real-World Settings

Tore K Kvien  1   2 , Neil Betteridge  3 , Ines Brückmann  4 , Wolfram Bodenmüller  4 , Galyna Bryn  4 , Silvio Danese  5 , João Gonçalves  6 , Zorana Maravic  7 , Carter Thorne  8 , Laura Wingate  9 , Paul Cornes  10
Affiliations
Review

Beyond Cost: Observations on Clinical and Patient Benefits of Biosimilars in Real-World Settings

Tore K Kvien et al. BioDrugs. 2025 Jul.

Abstract

The introduction of biosimilars into healthcare systems globally is recognized by many as a healthcare success. Despite this, questions have been raised about whether biosimilars can deliver sufficient value to patients and healthcare professionals, as well as sufficient cost saving, for their use in treatment to be worthwhile. In this review, we discuss how the increasing financial burden of complex therapeutic medicines, such as biologics, can be ameliorated by off-patent biosimilar medicines, particularly with increasing worldwide incidences of cancer and other chronic diseases. We then describe real-world cases that demonstrate the significant direct and indirect benefits of biosimilars to patients and healthcare systems beyond costs. Healthcare sustainability is crucial to ensuring that healthcare systems can continue to deliver high-quality care to patients. The savings realized from the introduction of biosimilars have expanded treatment options and improved access to therapies across a spectrum of diseases. Cost savings from biosimilar use have also led to changes in treatment guidelines, increasing the availability of biologic medicines for earlier lines of therapy. This expansion of access can have a positive impact on the overall patient experience and can reduce the overall disease burden. However, the adoption of biosimilars has not been universally successful, and faces challenges in the current healthcare landscape and in the pharmaceutical development pipeline.

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Conflict of interest statement

Declarations. Conflicts of Interest: T.K.K. reports fees for speaking and/or consulting from AbbVie, Amgen, Celltrion, Egis, Ewopharma, Gilead, Hikma, Janssen, Mylan, Novartis, Oktal, Pfizer, Sandoz, and UCB; and research funding from AbbVie, BMS, Galapagos, MSD, Novartis, Pfizer, and UCB. N.B. declares consultancy fees received from EULAR, Galapagos, Grunenthal, and Sanofi. I.B., W.B., and G.B. are employees of Sandoz. S.D. declares consultancy fees from AbbVie, Alimentiv, Allergan, Amgen, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Enthera, Ferring Pharmaceuticals, Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, TiGenix, UCB, and Vifor; and speaker fees from AbbVie, Amgen, Dr Falk Pharma, Ferring Pharmaceuticals, Gilead, Janssen, Mylan, Pfizer, and Takeda. J.G. declares speaker fees from AstraZeneca, Celltrion, Chiesi, Sandoz, and Sanofi. Z.M. has no conflicts of interest to declare. C.T. declares consultancy fees received from Biogen, Nordic, Pfizer, and Sandoz; advisory board fees from AbbVie, Nordic, Pfizer, Roche, and Sandoz; and research grants from Jamp and Pfizer. L.W. declares advisory fees received from Act4Biosimilars and PAN Therapeutics. P.C. declares speaker fees from Celltrion, Viatris (formerly Mylan), Pfizer, Novartis, and Sandoz. Funding: This study was funded by Sandoz Group AG. The funder had a role in the study design, data collection, data analysis, and manuscript preparation. The open access fee was also sponsored by Sandoz Group AG. Ethics Approval: Not applicable. Patient Consent to Participate/Publish: Not applicable. Availability of Data and Material: Data available on request. Code Availability: Not applicable. Author Contributions: I.B., W.B., and G.B. contributed to the study design, literature search, and data analysis. N.B., Z.M., C.T., and L.W. contributed to the study design, data analysis, and manuscript development. T.K.K., J.G., and P.C. contributed to the study design and manuscript development. All authors were involved in the preparation and review of the manuscript. All authors read and approved the final manuscript.

Figures

Fig. 1
Fig. 1
Clinical and patient benefits of biosimilars in real-world settings
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