Adalimumab biosimilar FKB327 causes less pain than originator

Biosimilars/Research | Posted 09/04/2021 post-comment0 Post your comment

Fujifilm Kyowa Kirin Biologics’ adalimumab biosimilar FKB327 has been found to cause less injection-site pain compared to the reference product, according to data from more than 1,001 subjects and patients [1]. 

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Adalimumab is a monoclonal antibody treatment for a range of autoimmune conditions including rheumatoid arthritis, inflammatory bowel disease, and psoriasis. It is given by subcutaneous injection, targets the inflammatory molecule tumour necrosis factor, and has been sold under the brand name Humira by the originator firm AbbVie.

The Japanese company Fujifilm Kyowa Kirin Biologics has developed a biosimilar adalimumab, known as FKB327, which received approval from the Japanese medicine regulatory agency in July [2].

Previous studies have confirmed similarity between FKB327 and the reference product in terms of safety profile, efficacy and immunogenicity. Notably, FKB327 does not have the same citrate-containing formulation as the reference product, which is used as a buffer and has been associated with pain upon injection.

In a recent study featured in GaBI Journal [1], researchers pooled data from four different studies in order to compare injection-site pain caused by FKB327 with that of the reference product. The researchers also compared pain caused by autoinjector, pre-filled syringe and vial/syringe formulations. Data analysed included a total of 2,007 assessments in 1,001 subjects and patients.

Pain at the injection site was assessed using a 100 mm visual analogue scale score. Subjects were asked to rate the extent of their pain by placing a mark on a line, with the left point of the line signifying no pain and the right point signifying intolerable pain.

Comparisons of the injection-site pain score across studies revealed a 12.6 point lower pain score for the biosimilar compared to the reference product. In terms of formulations, the autoinjector was found to have a pain score 4.4 points lower than the vial/syringe formulation, and 1.1 points lower than the pre-filled syringe formulation.

Overall, this study suggests the citrate-free formulation of FKB327 causes less injection-site pain than reference adalimumab. There were also no statistically significant differences in adverse events between the two forms of adalimumab, suggesting the biosimilar is equally as safe.

These findings suggest that receiving adalimumab biosimilar in the form of FKB327 administered by an autoinjector may reduce pain experienced by patients, which may in turn improve treatment adherence.

Conflict of interest
Several of the study authors declared competing interests. These can be read in full in the paper [1].

Editor’s comment
Readers interested to learn more about biosimilars of adalimumab are invited to visit to view the following manuscripts published in GaBI Journal:

Importance of manufacturing consistency of the glycosylated monoclonal antibody adalimumab (Humira®) and potential impact on the clinical use of biosimilars

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

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To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

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Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

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1. Alten R, Kellner H, Boyce M, et al. Systematic analysis of injection-site pain and reactions caused by subcutaneous administration of the adalimumab biosimilar FKB327 versus the adalimumab reference product via different delivery methods. Generics and Biosimilars Initiative Journal (GaBI Journal). 2020;9(3):108-15. doi:10.5639/gabij.2020.0903.019
2. GaBI Online - Generics and Biosimilars Initiative. Japanese approval for first adalimumab biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from:

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