Recommendations on TNFα inhibitor biosimilar use in clinical practice: a comparison of European gastroenterology IBD guidance

ABSTRACT

Background

Professional associations publish guidance advising gastroenterologists on prescribing biosimilars; however, guidelines differ between countries and change over time. This study aimed to map the presence and content of guidance from European gastroenterology associations on TNFα inhibitor biosimilar use and its development over time.

Research design and methods

Guidelines on biosimilar prescribing from national gastroenterology associations in the European Economic Area (EEA) partnered with the European Crohn’s and Colitis Organization (ECCO) were collected. Treatment guidelines and biosimilar position papers from 2010 to 2022 were included. Data were extracted using a template.

Results

26 of 30 EEA countries have an ECCO-partnered gastroenterology association, of which 14 (53.8%) had national guidelines addressing biosimilars, four (15.4%) followed ECCO’s position, and three (11.6%) had treatment guidelines without mentioning biosimilars. From five countries (19.2%) no guidelines were retrieved. Among 18 countries with guidance, 14 (77.8%) associations endorsed initiating biological treatment with biosimilars, and 13 (72.2%) endorsed transitioning from originator to biosimilar. Nine associations published multiple guidelines over time addressing biosimilars; overall, their positions became more encouraging.

Conclusions

The majority of gastroenterology associations endorsed biosimilar use. The lack of (up-to-date) guidelines for some associations indicates an area of improvement to support biosimilar use in clinical practice.

KEYWORDS:

• Biosimilar
• gastroenterology
• guidelines
• inflammatory bowel disease
• infliximab
• switching
• tumor necrosis factor inhibitors

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

RW Meijboom, L Barbier, LC Druedahl, K Sarnola, HM Tolonen, H Gardarsdottir, ACG Egberts, TJ Giezen contributed to the study design. RW Meijboom, L Barbier, LC Druedahl, K Sarnola, HM Tolonen contributed to the data collection and analysis. RW Meijboom wrote the first draft of the manuscript. All authors critically revised the manuscript. All authors approved the final version of the manuscript.

Data availability statement

Data are available upon request.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14712598.2023.2189008

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

LC Druedahl’s work in this paper was funded by the Collaborative Research Program for Biomedical Innovation Law, a scientifically independent research program supported by the Novo Nordisk Foundation (grant NNFSA0027784, grant recipient T Minssen).