Steven Jarrett1, Theodor Dingermann2. 1. Medication Safety Officer, Carolinas HealthCare System , Charlotte, North Carolina. 2. Professor, Institute for Pharmaceutical Biology , Frankfurt, Germany .
Abstract
BACKGROUND: Pharmacists are the recognized experts in pharmacotherapy. With the recent introduction of biosimilar agents into the US market, pharmacists are poised to play a pivotal role in evaluating their risks versus benefits within the framework of cost containment. PURPOSE: This article provides hospital pharmacists with the necessary information on the principles surrounding the development, approval process, and use of biosimilars. METHODS: Information contained in this article enables hospital pharmacists to identify concerns relating to biosimilars, implement educational components, and successfully evaluate biosimilars for the addition to the formulary. Additionally, this article reviews the European experience with biosimilars, the US Food and Drug Administration approval process, and postauthorization safety and pharmacovigilance programs. CONCLUSION: It is important to educate health care providers about the differences between biosimilars and their reference biologics. The adoption of biosimilars is necessary to control long-term costs of biologics, increase patient access to care, and encourage innovation.
BACKGROUND: Pharmacists are the recognized experts in pharmacotherapy. With the recent introduction of biosimilar agents into the US market, pharmacists are poised to play a pivotal role in evaluating their risks versus benefits within the framework of cost containment. PURPOSE: This article provides hospital pharmacists with the necessary information on the principles surrounding the development, approval process, and use of biosimilars. METHODS: Information contained in this article enables hospital pharmacists to identify concerns relating to biosimilars, implement educational components, and successfully evaluate biosimilars for the addition to the formulary. Additionally, this article reviews the European experience with biosimilars, the US Food and Drug Administration approval process, and postauthorization safety and pharmacovigilance programs. CONCLUSION: It is important to educate health care providers about the differences between biosimilars and their reference biologics. The adoption of biosimilars is necessary to control long-term costs of biologics, increase patient access to care, and encourage innovation.
Authors: Martin Schiestl; Jing Li; Arpah Abas; Antonio Vallin; Jennifer Millband; Kai Gao; Jeewon Joung; Stefanie Pluschkell; Thomas Go; Hye-Na Kang Journal: Biologicals Date: 2013-12-24 Impact factor: 1.856
Authors: Pere Gascón; Hans Tesch; Karl Verpoort; Maria Sofia Rosati; Nello Salesi; Samir Agrawal; Nils Wilking; Helen Barker; Michael Muenzberg; Matthew Turner Journal: Support Care Cancer Date: 2013-08-01 Impact factor: 3.603