Zlatkus Andrea, Bixby Todd, Goyal Kavitha
Chester County Rheumatology PC, West Chester, PA, USA.
Janssen Scientific Affairs, LLC, Horsham, PA, USA.
Drugs Context. 2020 Feb 25;9. doi: 10.7573/dic.2019-12-1. eCollection 2020.
As numerous biosimilar products are forecast to enter the US market in the coming years, health-system pharmacists will be faced with novel challenges while incorporating them into clinical practice. The current regulatory approval framework and guidance from the US Food and Drug Administration do not address many real-world scenarios that pharmacists will encounter. We provide an overview of the evolving healthcare landscape shaped by the entry of multiple biosimilars, including for a given reference product, and their impact on the health-system pharmacist with respect to formulary assessment, implementation, and education of various health-system stakeholders, including patients.
由于预计未来几年将有大量生物类似药产品进入美国市场，医疗系统的药剂师在将它们纳入临床实践时将面临新的挑战。美国食品药品监督管理局当前的监管批准框架和指南并未涉及药剂师将会遇到的许多实际情况。我们概述了由多种生物类似药进入所形成的不断演变的医疗格局，包括针对某一特定参照产品的情况，以及它们在处方集评估、实施以及对包括患者在内的各类医疗系统利益相关者进行教育等方面，对医疗系统药剂师的影响。
