Recommendations for the use of biosimilars in rheumatic diseases

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Biological therapies have become a central part of the long-term management of many chronic diseases, including inflammatory rheumatic diseases. V13H09

Over the past decade, the availability of targeted biologicals has revolutionized the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. However, the significant cost of these biologicals is often prohibitive and limits universal access to these effective therapeutic agents. This paves the way for increasing the use of biosimilars in the field of rheumatology.

In order to come to a consensus that would provide recommendations for the use of biosimilars in The Netherlands, a task force was created [1]. This task force consisted of 28 clinical experts, two pharmacologists and two patients. The task force carried out a systemic literature search focussing on phase I – III studies, the risk of extrapolation, immunogenicity, switching (efficacy, safety) and harmonization of registries.

The results of the literature search led to the following overarching principles and recommendations:

Consensus: overarching principles

  • Treatment of rheumatic diseases is based on shared decisions between patients and rheumatologists
  • Contextual aspects of the healthcare system should be taken into account
  • Biosimilars are neither worse nor better than their originators
  • Patients and healthcare providers need to be educated about biosimilars
  • There is a need for harmonized methods for pharmacovigilance

Consensus: recommendations

  • Biosimilars should significantly lower treatment costs
  • Approved biosimilars can be used
  • No need to measure anti-drug antibodies
  • Relevant phase I data should be published before phase III trials are carried out
  • Extrapolation is safe and effective
  • Switching is safe and effective; multiple switches should be assessed
  • No switches should be made without the knowledge of patients/rheumatologists

The first biosimilar for the treatment of inflammatory conditions (CT-P13) was authorized in 2013 by the European Medicines Agency [2]. It has been estimated that use of CT-P13 could lead to significant cost savings in Europe [3]. In light of increasing pressure on healthcare budgets biosimilars are becoming an increasingly attractive option to reduce costs, especially when it comes to chronic conditions.

Related article
Biosimilars for rheumatic diseases

1. Breedveld FC. Convergence between regulatory science and the medical practice. Consensus –based recommendations on biosimilars in rheumatic diseases. 15th Biosimilar Medicines Conference. Biosimilar medicines: a game changer for healthcare sustainability; 23−24 March 2017; London, UK.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 13]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Economic considerations for rheumatoid arthritis biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 13]. Available from:

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