Aoki Yoshiko, Sai Kimie, Katsuta Yukiko, Suzuki Mika, Suzuki Yasuo, Ishii-Watabe Akiko, Saito Yoshiro
Division of Medicinal Safety Science, National Institute of Health Sciences.
IBD Center, Toho University Sakura Medical Center.
Yakugaku Zasshi. 2022 May 1;142(5):547-560. doi: 10.1248/yakushi.21-00216. Epub 2022 Feb 22.
Biosimilars are less expensive than their originators, and Japanese government policies call for their development and promotion. However, the adoption and prescription of some biosimilars, especially antibody/its-related ones, have been delayed for use in Japan, possibly due to concerns on the differences in quality attributes such as glycan structures between the originators and their biosimilars, and that clinical efficacy/safety studies are conducted for usually one disease and its results extrapolated to other indications. We conducted a questionnaire survey among physicians in four disease areas (hematology, medical oncology, rheumatoid arthritis, and inflammatory bowel disease), where biosimilars of antibody/its-related drugs have been approved, regarding their thoughts on the adoption and prescription of biosimilars in Japan from January to April 2020. We received totally 1024 responses. When adopting biosimilars and explaining them to patients, physicians requested specific information including the comparative results of phase III clinical trials and quality characteristics between biosimilars and their originators; the results of clinical studies on switching from originators to their biosimilars; and a comparison of the estimated cost on patients in consideration of the high medical cost payment system. Priority differed depending on the studied disease areas. In terms of post-marketing information, physicians requested a variety of information. When explaining biosimilars to the patients, physicians would like to use general material from government describing the comparability between originators and their biosimilars. These results suggest that physicians sought more comparative information on the quality, efficacy, and patients' cost between originators and their biosimilars when adopting or prescribing biosimilars.
生物类似药比其原创药价格更低，日本政府政策提倡对其进行研发和推广。然而，一些生物类似药，尤其是抗体及其相关药物的采用和处方在日本的使用有所延迟，这可能是由于对原创药与其生物类似药之间质量属性差异（如聚糖结构）的担忧，以及临床疗效/安全性研究通常针对一种疾病进行，其结果外推至其他适应症。我们于2020年1月至4月对四个疾病领域（血液学、医学肿瘤学、类风湿性关节炎和炎症性肠病）的医生进行了问卷调查，这些领域中抗体及其相关药物的生物类似药已获批准，问卷内容涉及他们对日本生物类似药采用和处方的看法。我们共收到1024份回复。在采用生物类似药并向患者解释时，医生们要求提供具体信息，包括III期临床试验的比较结果以及生物类似药与其原创药之间的质量特征；从原创药转换为生物类似药的临床研究结果；以及考虑到高额医疗费用支付系统后对患者估计费用的比较。不同疾病领域的优先级有所不同。在上市后信息方面，医生们要求提供各种信息。在向患者解释生物类似药时，医生们希望使用政府提供的描述原创药与其生物类似药可比性的一般资料。这些结果表明，医生在采用或处方生物类似药时，寻求更多关于原创药与其生物类似药之间质量、疗效和患者成本的比较信息。
