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专科医生对生物类似药的认知、了解及看法。

Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians.

作者信息

Cohen Hillel, Beydoun Donna, Chien David, Lessor Tracy, McCabe Dorothy, Muenzberg Michael, Popovian Robert, Uy Jonathan

机构信息

Sandoz Inc., Princeton, NJ, USA.

Merck & Co., Inc., Kenilworth, NJ, USA.

出版信息

Adv Ther. 2017 Jan;33(12):2160-2172. doi: 10.1007/s12325-016-0431-5. Epub 2016 Oct 31.

Abstract

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.

FUNDING

Biosimilars Forum.

摘要

引言

生物类似药论坛于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,以评估美国已经开具生物制剂处方的专科医生对生物类似药的当前认知水平、知识水平和看法。该调查旨在提供有关生物类似药的基线知识水平,并将在2至3年内重复进行,以便监测随时间的趋势。

方法

生物类似药论坛创建了一份包含19个问题的调查问卷,并由一个独立第三方进行管理。

结果

从1201名美国各专科医生处获得了回复,这些专科医生都是生物制剂的高处方者,包括皮肤科医生、胃肠病学家、血液肿瘤学家、医学肿瘤学家、肾病学家和风湿病学家。

结论

本次调查结果凸显了对各专科医生进行基于证据的生物类似药教育的迫切需求。确定了五个主要知识差距:定义生物制剂、生物类似药和生物相似性;理解批准程序以及使用“全部证据”来评估生物类似药;理解生物类似药的安全性和免疫原性与原研生物制剂相当;理解适应症外推的基本原理;以及定义可互换性和关于药房层面替换的相关规则。

资金来源

生物类似药论坛。

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