Real-world data on biosimilars in inflammatory arthritis treatment

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The use of biologicals in patients with rheumatic diseases has achieved the therapeutic target, i.e. remission or low disease activity. The share of biologicals has been growing with the approval of biosimilars, which have been recognized for their equivalent efficacy, safety, pharmacokinetics and immunogenicity to the originator, as well as their reduced economic burden.

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Biosimilars are being examined for their bioequivalence to reference products in randomized controlled trials; however, the use of biosimilars in actual clinical practice is complicated owing to issues with switching and co-morbidities. Therefore, Korean researchers carried out a review of real-world data in the rapidly evolving field of biosimilars in the treatment of rheumatoid arthritis and spondyloarthropathy, including ankylosing spondylitis and psoriatic arthritis [1].

The results showed that biosimilars lead to an increase in patient access to effective biological treatments by providing cost-effective alternatives to originators. A significant number of biosimilars have been approved by the European Medicines Agency (EMA) [2] and the US Food and Drug Administration (FDA) [3].

Numerous observational studies on the biosimilars of infliximab and etanercept proved to be similar in biological activity, as well as efficacy, safety and immunogenicity. Despite the similarity between the originator and the biosimilar, the nocebo effect occurred in real-world data due to the negative perception of the patients.

Observation studies on rituximab, which have not yet been widely published, are also expected to increase significantly. According to published data, the use of biosimilars for inflammatory arthritis led to no significant inferiority in treatment outcomes and resulted in considerable cost savings in the real world.

The authors concluded that ‘beyond the use of biosimilars, issues with the interchangeability of biosimilars, including immunogenicity, should be addressed’. They added that ‘strategies to overcome these concerns will improve treatment efficacy and safety in patients with inflammatory arthritis’.

Conflict of interest
The authors of the research paper [1] reported conflict of interest, including having received consulting fees from Celltrion. For full details of the authors’ conflicts of interest, see the research paper [1].

Abstracted by Chang-Hee Suh, MD, PhD, Professor & Director of the Department of Rheumatology, Ajou University School of Medicine, South Korea.

Editor’s comment
Readers interested to learn more about use of biosimilars in the treatment of rheumatoid arthritis are invited to visit to view the following manuscript published in GaBI Journal.

Assuring patient-centred care: engaging patients with rheumatoid arthritis in disease monitoring and pharmacovigilance

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1. Kim JW, Jung JY, Suh CH. Real-world observational study of biosimilars in inflammatory arthritis treatment: a systematic literature review. Expert Opin Biol Ther. 2020:1-17.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from: 
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from:

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