Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians
Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians
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DOI：
10.1007/s12325-016-0431-5
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发表时间：
2017-01-01
影响因子：
3.8
通讯作者：
Uy, Jonathan
中科院分区：
文献类型：
--
作者：
Cohen, Hillel;Beydoun, Donna;Uy, Jonathan
简介：生物仿制药论坛于2015年11月20日至2016年1月4日通过一个独立组织进行了一项调查，以评估已经开生物制剂处方的美国专科医生对生物仿制药的认知、知识和看法的当前水平。该调查旨在提供有关生物类似药的基本知识水平，并将在2-3年内重复进行，以监测随着时间的推移趋势。方法：由生物类似药论坛创建了一项19个问题的调查，并由独立的第三方管理。结果：从1201名美国医生那里获得了回复，这些医生是生物制品的高处方者，包括皮肤科医生，胃肠病学家，结论：本次调查的结果强调了对跨专业医生进行生物仿制药循证教育的重要性。确定了五个主要的知识差距：定义生物制剂，生物仿制药和生物相似性;理解批准过程和使用“证据的整体性”来评估生物仿制药;理解生物仿制药的安全性和免疫原性与原研生物制剂相当;理解外推适应症的基本原理;以及定义可替代性和关于药物水平替代的相关规则。
Introduction: The Biosimilars Forum conducted a survey through an independent organization from November 20, 2015 to January 4, 2016 in order to assess current levels of awareness, knowledge, and perceptions of biosimilars among US specialty physicians who already prescribe biologics. The survey was intended to provide a baseline level of knowledge about biosimilars and will be repeated in 2-3 years in order to monitor trends over time.Methods: A 19-question survey was created by the Biosimilars Forum and was administered by an independent third party.Results: Responses were obtained from 1201 US physicians across specialties that are high prescribers of biologics, including dermatologists, gastroenterologists, hematologist-oncologists, medical oncologists, nephrologists, and rheumatologists.Conclusions: The results of this survey highlight a significant need for evidence-based education about biosimilars for physicians across specialties. Five major knowledge gaps were identified: defining biologics, biosimilars, and biosimilarity; understanding the approval process and the use of "totality of evidence" to evaluate biosimilars; understanding that the safety and immunogenicity of a biosimilar are comparable to the originator biologic; understanding the rationale for extrapolation of indications; and defining interchangeability and the related rules regarding pharmacy-level substitution.