This study evaluated a biosimilar of etanercept, which is a biological treatment for autoimmune diseases including rheumatoid arthritis (RA). It has been marketed by the originator company Amgen as Enbrel and works by inhibiting the inflammatory molecule tumour necrosis factor.

The biosimilar candidate is called YLB113 and is manufactured by the Japanese firm YL Biologics, a joint venture between Lupin and Yoshindo [2]. The biosimilar received approval from the Japanese medicine regulatory agency in March 2019 [3]. Phase III trials of the product have confirmed no statistically significant differences in efficacy and safety to the originator product [4].

In this study, the research team evaluated the convenience and patient experience of the use of a pen formulation of YLB113 among patients with RA, who were enrolled on a phase III trial and switched from a pre-filled syringe to an injection pen formulation. The study was conducted as a part of a phase III study in Japan conducted by YL Biologics.

A total of 35 patients (10 male, 25 female) met the recruitment criteria and were administered a pen usability survey. Prior to enrolling in the study, participants responded to a survey that evaluated fear of injection, fear of self-injection, and injection pain using a syringe. At the end of the 8-week study, participants answered the same questions for the self-injection pen device, in addition to questions about operability and convenience.

The results found that 74% of patients preferred self-injecting the biosimilar using the injection pen over the syringe formulation. Most participants reported that using the injection pen was easier, more comfortable, and less fear-inducing than using the syringe. Most patients also reported that the pen was easy to grasp.

Patients generally reported that the clicking feature that signals the start and end of the injection could be heard well and that the injection solution check window was easy to see. No pen defects or treatment discontinuations occurred during the study period, however, adverse events associated with YLB113 occurred in 15 patients, the most common being infection.

Although a minority of patients reported pain from the injection pen and said they would prefer to use a syringe, overall, these results suggest the YLB113 injection pen is well tolerated, easy to use, and preferable over pre-filled syringe preparations for etanercept injections.

Limitations of the study include its observational nature (lacking a control arm of patients) and the results being self-reported by patients. Further and larger studies of the operability and convenience of the YLB113 injection pen would be beneficial.

Conflict of interest
Three 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 injection-site pain of biologicals are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

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

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References
1. Hibino T, Yoshida T, Sagawa A, et al. Qualitative survey-based evaluation of operability and convenience for the etanercept biosimilar YLB113 in a unique injection pen in patients with rheumatoid arthritis. Generics and Biosimilars Initiative Journal (GaBI Journal). 2020;9(3):100-7. doi:10.5639/gabij.2020.0903.018.
2. GaBI Online - Generics and Biosimilars Initiative. Lupin and Yoshindo start biosimilars joint venture [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Biosimilars/News/Lupin-and-Yoshindo-start-biosimilars-joint-venture 
3. GaBI Online - Generics and Biosimilars Initiative. Japanese approval for Lupin’s etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Biosimilars/News/Japanese-approval-for-Lupin-s-etanercept-biosimilar 
4. GaBI Online - Generics and Biosimilars Initiative. Yoshindo and Lupin’s etanercept biosimilar completes trials [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Biosimilars/Research/Yoshindo-and-Lupin-s-etanercept-biosimilar-completes-trials

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