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Authors
Car, Elif https://orcid.org/0000-0003-4356-4722
Barbier, Liese https://orcid.org/0000-0003-1786-2080
Schwarzenberger, Ingrid
Huys, Isabelle https://orcid.org/0000-0002-4738-8298
Simoens, Steven https://orcid.org/0000-0002-9512-2005
Vulto, Arnold G. https://orcid.org/0000-0002-8439-2800
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Funding
Funding for this research was provided by:
Market Analysis of Biologics and Biosimilars following Loss of Exclusivity (MABEL) Fund
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Article History
Accepted: 21 September 2025
First Online: 21 October 2025
Declarations
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: SS, IH, and AV are founders of the KU Leuven Fund on Market Analysis of Biologics and Biosimilars following Loss of Exclusivity (MABEL Fund). AV is involved in consulting, advisory work and speaking engagements for a few companies, i.e., Accord, Amgen, Biogen, Effik, Medicines for Europe, Pfizer/Hospira, Novartis, and Sandoz. SS was involved in a stakeholder roundtable on biologics and biosimilars sponsored by Amgen, Pfizer and MSD; he has participated in advisory board meetings for Pfizer, Organon and Amgen; he has contributed to studies on biologics and biosimilars for Hospira, Celltrion, Mundipharma, Pfizer and Biogen; and he has had speaking engagements for Abbott, Amgen, Biogen, Celltrion, and Sandoz. IS is an independent regulatory consultant with a long-standing background in biosimilars as an ex-affiliate to Sandoz. As such, she had speaking engagements for Sandoz in the past and served as the Chair of the Biosimilars Committee of IGBA. EC and LB have no conflicts of interest to declare. All authors declare that the research was conducted in the absence of any commercial or financial relationship that could be construed as a potential conflict of interest.
: The datasets supporting the findings of this study are not publicly available due to the presence of sensitive information that could potentially identify participants and compromise their privacy. The data are, however, available from the authors upon reasonable request. For further information, please contact the corresponding author (a.vulto@erasmusmc.nl) .
: The study was approved by the Ethics Committee Research of UZ/KU Leuven (S67464). Written informed consent was obtained from all participants.
: Not applicable.
: Not applicable.
: Not applicable.
: Study concept and design: all authors. Data collection: EC, SS, and AV. Data analysis: EC. Interpretation of data: all authors. Drafting of the manuscript: EC. Critical revision of the manuscript: all authors. All authors read and approved the final version of the manuscript.
