Joint statement on biosimilars in immune-mediated diseases in Spain

Biosimilars/General | Posted 30/05/2023 post-comment0 Post your comment

A study conducted and published by Monte-Boquet E et al. aimed to improve knowledge and use of biosimilar medicines in immune-mediated diseases, and to produce a unified framework for the use of biosimilars [1].

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By the end of 2022, in Spain, there was over 50 biosimilar drugs available, corresponding to 16 active ingredients, four of which are for immune-mediated rheumatologic, dermatologic, and digestive diseases: adalimumab (ADA), etanercept (ETN), infliximab (IFX), and rituximab (RTX). The first biosimilar drug for this group of diseases was approved in 2015 and was for IFX. Since then, biosimilar drugs have been widely used in the country [2]. 

In the rapidly evolving field of biosimilars, improving knowledge and promoting optimal use among healthcare professionals is crucial. To address this need, a comprehensive literature review was conducted by Monte-Boquet E et al. and consulted with a diverse group of biosimilar drug expert. This multidisciplinary team consisted of a dermatologist, a hospital pharmacist, a rheumatologist, and a gastroenterologist [1].

The study was carried out taking also into account the variable level of knowledge in Spain regarding the multiple aspects of biosimilar medicines, such as their development, fundamentals, access or use in clinical practice [1].

The outcome of this work resulted in a document intended to serve as a reference for healthcare professionals who work in the management of patients with immune-mediated diseases treated with biosimilar medicines.

The primary objective of this study was two-fold: 1) to enhance the knowledge and use of biosimilar medicines in immune-mediated diseases; and 2) to establish a consensus framework for their optimal use in the treatment of such conditions.

For this purpose, a qualitative study was designed. The multidisciplinary team of experts in biosimilar drugs was selected to define the objectives, scope, users, and sections to be developed in the document. These included:

  1. Main features of biosimilar drugs (definition, development, approval, indication extrapolation, interchangeability, financing and traceability).
  2. Evidence (biosimilarity, efficacy, effectiveness, safety, immunogenicity, efficiency, switch).
  3. Barriers and facilitators to their use.
  4. Patient information. Based on this, a literature review was conducted.

An exhaustive narrative review of the medical literature in Medline was conducted to find relevant articles on biosimilar drugs. Studies including systematic reviews, preclinical, clinical, and real-life studies were selected. Based on the gathered information, a set of principles and general recommendations were established. To evaluate the level of agreement with these recommendations, a Delphi process was carried out with the participation of 66 healthcare professionals. Each participant voted on a scale from 1 to 10, where 1 meant total disagreement and 10 meant complete agreement. Agreement was considered to exist if at least 70% of the participants voted ≥ 7.

The literature review included 555 articles and 10 general principles and recommendations were established through the Delphi method. The document provides detailed information about biosimilar medicines, including their definition, development, approval, extrapolation of indications, interchangeability, funding, and traceability. It also addresses the published evidence on biosimilarity, efficacy, effectiveness, safety, immunogenicity, efficiency, and switching, as well as the barriers and facilitators to their use and information for patients.

The study concluded that the biosimilar drugs that have been approved meet the necessary requirements of quality, efficacy, and safety, and can be a valuable tool for improving the availability of biological therapies for patients, as well as helping to ensure the sustainability of healthcare systems.

Back in April 2021, Marín-Jiménez I et al. published a survey report of hospital pharmacists and specialty physicians, showing that there was high level of knowledge gaps in biosimilar development, switching, extrapolation and interchangeability/substitution [3].

Conflict of interest
This work [1] was funded by an unrestricted grant from Fresenius Kabi España. 

The authors of the research paper [1] declared that there was various conflict of interest.

For full details of the authors’ conflict of interest, see the research paper [1].

Editor’s comment
Readers interested to learn more about biologicals and biosimilars are invited to visit to view the following manuscript published in GaBI Journal:

Biologicals and biosimilars: a review of the science and its implications

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1. Monte-Boquet E, Florez A, Alcaín Martínez GJ, et al. Documento de consenso sobre los medicamentos biosimilares en enfermedades inmunomediadas en España, Reumatología Clínica. 2023. ISSN 1699-258X,
2. Cornejo Uixeda S, Quintana Vergara B, Sánchez Alcaraz A. Análisis de la utilización de medicamentos biosimilares. Rev OFIL·ILAPHAR. 2020;30(1):80-1. 
3. GaBI Online - Generics and Biosimilars Initiative. Survey results of biosimilars use among Spanish physicians and pharmacists []. Mol, Belgium: Pro Pharma Communications International; [cited 2023 May 30]. Available from:

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