J Drugs Dermatol. 2024 Apr 1;23(4):277-280. doi: 10.36849/JDD.7755.
Biosimilars are biologic agents the Food and Drug Administration (FDA) has deemed to have no clinical difference from their reference biologics. In dermatology, biosimilars are approved for the treatment of psoriasis and hidradenitis suppurativa. Although dermatologists are high prescribers of biologics, they are more reluctant to prescribe biosimilars than other specialists. This survey-based study sought to characterize dermatologists’ current perspectives on biosimilars. Methods: A 27-question survey was distributed via email to dermatologists between September and October of 2022. Results: Twenty percent of respondents would not prescribe a biosimilar for an FDA-approved indication. When asked about the greatest barriers to biosimilar adoption, 61% had concerns about biosimilar safety and efficacy, 24% reported uncertainty about state laws for interchangeability and substitutions, and 20% had concerns about biosimilar safety without concerns about efficacy. Thirty-five percent of respondents felt moderately or extremely knowledgeable about biosimilar interchangeability. Conclusion: Biosimilars are safe and effective for treating approved dermatological conditions and may lower patient costs compared to their reference products. Patients are not always offered biosimilar therapy as an option, which may be due to unfamiliarity among dermatologists. This survey suggests a need for more research and educational initiatives, such as modules and workshops that focus on biosimilar safety, efficacy, and interchangeability guidelines. J Drugs Dermatol. 2024;23(4):doi:10.36849/JDD.7755.
生物类似药是指食品和药物管理局 (FDA) 认定与参比生物制剂在临床方面没有差异的生物制剂。在皮肤科,生物类似药已被批准用于治疗银屑病和化脓性汗腺炎。尽管皮肤科医生是生物制剂的大量处方者,但他们比其他专科医生更不愿意开生物类似药。这项基于调查的研究旨在描述皮肤科医生目前对生物类似药的看法。方法:在 2022 年 9 月至 10 月期间,通过电子邮件向皮肤科医生分发了一份包含 27 个问题的调查问卷。结果:20%的受访者不会为 FDA 批准的适应症开生物类似药。当被问及采用生物类似药的最大障碍时,61%的人对生物类似药的安全性和疗效表示担忧,24%的人报告说对州际互换来替代的法律不确定,20%的人担心生物类似药的安全性而不担心疗效。35%的受访者认为自己对生物类似药的可互换性有中等或极高的了解。结论:生物类似药安全有效,可用于治疗已批准的皮肤科疾病,与参比产品相比,可能降低患者的成本。患者并不总是被提供生物类似药治疗作为一种选择,这可能是由于皮肤科医生对此不熟悉。这项调查表明需要开展更多的研究和教育计划,例如关注生物类似药安全性、疗效和可互换性指南的模块和研讨会。J 皮肤病药物学杂志。2024;23(4):doi:10.36849/JDD.7755.