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薬理と治療
Abstract
Background In September 2009, the first biosimilar received market authorization, and 15 ingredient biosimilar products for the originators have been approved by May 2021. The number of products that can be self-injected is also increasing, and those products are dispensed at community pharmacies. It is important for community pharmacists to understand biosimilars in order to promote their usage. We conducted a questionnaire survey on the awareness of biosimilars for pharmacists. Methods The questionnaire survey was conducted on the web for the supervising pharmacists working in the pharmacies as the member of Japan Pharmaceutical Association or in the pharmacies as the member companies of Nippon Pharmacy Association. Results 2887 responses were obtained. 67.1% of pharmacies received prescriptions related to biosimilars, and 69.0% of prescriptions were specified the biosimilar brand. When a prescription without tick mark on the field of non-substitutable was received, 46.3% of pharmacists dispensed originators without confirming prescribed doctor, and 31.0% asked prescribed doctor whether they could dispense an originator or a biosimilar. A relatively large number of respondents concerned about substitution of biosimilars for originators compared to other items regarding concerns on biosimilars. The highest percentage of the respondents pointed out that substitution rules are important for promoting use. Conclusions It is important for regulatory authorities to disseminate information and implement training program on biosimilars, and it was considered necessary to establish standards for substitution rules. The medical fee schedule should be designed in consideration of inventory burden of biosimilars and required time for consultation with patients.
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