Japanese government policies, such as the Honebuto policy [2], have been designed to encourage the development, manufacturing, and marketing approval of biosimilars. As of April 2021, 31 biosimilar products for 16 originators have been approved in Japan [3]. However, the adoption and prescription of some biosimilars, especially antibody-related products (including infliximab, adalimumab and bevacizumab), has been delayed.

To help promote biosimilar usage in clinical settings in Japan, Aoki et al. conducted a survey of opinions of physicians regarding the adoption and prescription of biosimilars from January to April 2020 [1]. They received responses from physicians in haematology (215 of 484 physicians), medical oncology (499 of 2,105), rheumatoid arthritis (269 of 1,000), and inflammatory bowel disease (IBD, 41 of 240).

The survey reports that, when adopting biosimilars in hospitals and explaining their usage to patients, the physicians requested information on the comparative results of quality characteristics and phase III clinical trials between biosimilars and their originators, the results of clinical studies on switching from originators to their biosimilars, and a comparison of the estimated cost burden on patients when changing from the originator to a biosimilar. The priority of the information type requested depended on the disease area. For example, results of switching studies were predominantly requested by physicians treating those with rheumatoid arthritis and IBD, where long-term drug treatments are usually needed. For explanations of biosimilar usage to their patients, the physicians requested materials on general comparability between biosimilars and originator biologics published by the government, and comparability of efficacy and safety in clinical trials for specific biosimilars. Physicians also requested a variety of post-marketing information including results of surveillance for indications assessed in the clinical trials, results of clinical studies on the switching from originators to biosimilars, database results of comparative studies on efficacy and safety, and results of clinical studies on approved indications based on the extrapolation from other indications that clinical study was performed.

The survey study also highlights that, for the selection, adoption, and prescription of biosimilars, physicians first raised concerns regarding comparability in efficacy (followed by safety and quality) between biosimilars and originators in all disease areas. To alleviate these concerns, substantial information on the comparability between biosimilars and originators (in all four disease areas), and also on the reduction in patient costs (in rheumatoid arthritis) were necessary.

The study also shows that, the first approved biosimilar product for each originator was the most commonly used among the approved biosimilars in Japan.

Overall, it is clear that, prior to adopting biosimilars, physicians felt they needed to request comparative information on the quality, efficacy, safety, and cost burden to the patient between originators and their biosimilars. Although many clinical studies report that no efficacy or safety problems have been observed with infliximab, etanercept and adalimumab when switched from the originator to a biosimilar, this information had to be requested. The study highlights that establishing a knowledge base or database to provide such information is expected to promote clinical use. In addition to efficacy and safety, comparative information on quality should be provided to physicians in an ‘easy to understand’ manner. Furthermore, it would be useful to have websites, mobile applications and software that can calculate patients’ costs under various scenarios (including dosage, duration of administration, and health insurance payment system) are needed in different countries.

Confidence in biosimilars and competitive pricing can improve their uptake, and this has also been recently highlighted in another survey of rheumatologists that showed that the uptake of biosimilars in Japan had increased to 78% between 2018 and 2020, with only 6% of prescribers preferring to prescribe originators by 2020 [4].

Conflict of interest
The author of the research paper [1] declared that there was no conflict of interest.

Abstracted by Yoshiro Saito, PhD, Director, Division of Medicinal Safety Science, National Institute of Health Sciences, Ministry of Health, Labour and Welfare, Japan.

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References
1. Aoki Y, Sai K, Katsuta Y, et al. Questionnaire survey on adoption and prescription of biosimilars (antibody and its-related products) by medical doctors in Japan. Yakugaku Zasshi. 2022; doi: 10.1248/yakushi.21-00216. Online ahead of print.
2. GaBI Online - Generics and Biosimilars Initiative. Asia Pacific countries: future demand for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 May 20]. Available from: www.gabionline.net/biosimilars/research/Asia-Pacific-countries-future-demand-for-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 May 20]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-Japan
4. GaBI Online - Generics and Biosimilars Initiative. Rheumatologists are prescribing more biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 May 20]. Available from: www.gabionline.net/reports/rheumatologists-are-prescribing-more-biosimilars

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