Background

Biosimilars account for 30–40% of biologic medications dispensed in the United States (US), yet healthcare providers in relevant medical specialties have limited awareness of biosimilars and their characteristics. Likewise, many providers perceive biosimilars as less safe and effective than original biologics and are more comfortable prescribing original biologics to patients.

Methods

We conducted in-person focus groups at three clinical sites in California and Texas (n = 49) to explore the reasons behind US healthcare providers’ limited understanding of, cautious attitudes toward, and reluctance to prescribe biosimilars. We conducted thematic analysis by having three researchers independently analyze verbatim transcripts and identify patterns in provider responses.

Results

Providers’ limited knowledge of and cautious attitudes toward biosimilars are driven by uncertainty about how biosimilarity is defined and operationalized as well as negative past experiences with generic drugs that did not perform as well as branded counterparts. Additionally, healthcare providers are unfamiliar with the Food and Drug Administration’s (FDA’s) approval pathway for biosimilars and are skeptical that an abbreviated approval process is rigorous enough to ensure biosimilars deliver the same efficacy and have the same side effect profiles as original biologics. Physicians also expressed concerns about pharmacy substitution of biosimilars and interchangeables, explaining they would be unaware of which medication was ultimately given to their patients.

Conclusions

Educating physicians and pharmacists about biosimilars—including how biosimilarity is defined and operationalized, the structure of the biosimilar approval process, and how analytical data can ensure biosimilar safety and efficacy—will be important for reducing healthcare providers’ concerns and increasing biosimilar adoption in the US.

中文翻译：

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了解美国医生和药剂师对生物仿制药的态度：一项定性研究

背景

生物仿制药占美国 (US) 分发的生物药物的 30-40%，但相关医学专业的医疗保健提供者对生物仿制药及其特性的认识有限。同样，许多提供者认为生物仿制药不如原始生物制剂安全和有效，并且更愿意为患者开原始生物制剂。

方法

我们在加利福尼亚州和得克萨斯州的三个临床地点 ( n = 49)进行了面对面的焦点小组讨论，以探讨美国医疗保健提供者对生物仿制药的了解有限、持谨慎态度和不愿开具生物仿制药处方背后的原因。我们通过让三名研究人员独立分析逐字记录并确定提供者回应中的模式来进行主题分析。

结果

供应商对生物仿制药的有限了解和谨慎态度是由于生物仿制药的定义和操作方式存在不确定性，以及过去仿制药的负面经验导致其​​性能不如品牌仿制药。此外，医疗保健提供者不熟悉食品和药物管理局 (FDA) 的生物仿制药审批途径，并且怀疑简化的审批流程是否足够严格以确保生物仿制药具有与原始生物制剂相同的功效和相同的副作用。医生还对生物仿制药和可互换药的药房替代表示担忧，解释说他们不知道最终给患者服用的是哪种药物。

结论

对医生和药剂师进行生物仿制药方面的教育——包括生物仿制药的定义和实施方式、生物仿制药审批流程的结构以及分析数据如何确保生物仿制药的安全性和有效性——对于减少医疗保健提供者的担忧和提高生物仿制药在美国的采用率非常重要.