Considerations for the US health-system pharmacist in a world of biosimilars

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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 healthsystem pharmacist with respect to formulary assessment, implementation, and education of various health-system stakeholders, including patients.

Keywords: biologics, biosimilars, clinical pharmacists, drug substitution, pharmacoeconomics, rheumatology.

Citation: Zlatkus A, Bixby T, Goyal K. Considerations for the US healthsystem pharmacist in a world of biosimilars. Drugs in Context 2020; 9: 2019-12-1. DOI: 10.7573/dic.2019-12-1

Contributions: T Bixby and K Goyal developed the concept for this editorial. All authors wrote the editorial and approved of the final draft. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Disclosure and potential conflicts of interest: T Bixby and K Goyal are employees of Janssen Scientific Affairs, LLC, a subsidiary of Johnson & Johnson, and own stock in Johnson & Johnson. A Zlatkus reports personal fees from Janssen, Genentech, AbbVie, Lilly, and Novartis for speakers’ bureau activities; Janssen for training and video; and Genentech, AbbVie, Novartis, UCB, Samumed, and Sanofi for participation in advisory boards, all of which were outside the submitted work. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at

Acknowledgments: The authors would like to acknowledge the editorial assistance and subject matter expertise provided by Richard Melsheimer, of Janssen Scientific Affairs, LLC. Editorial and medical writing support for this manuscript were provided by Tiffany DeSimone, PhD, of Ashfield Healthcare Communications.

Funding declaration: Development of this manuscript and the editorial and medical writing support were funded by Janssen Biologics.

Copyright: Copyright © 2020 Zlatkus A, Bixby T, Goyal K. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Correct attribution: Copyright © 2020 Zlatkus A, Bixby T, Goyal K. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0.

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Correspondence: Todd Bixby, Janssen Scientific Affairs, LLC, 800 Ridgeview Drive, Horsham, PA 19044, USA.

Provenance: submitted; externally peer reviewed.

Submitted: 17 December 2019; Peer review comments to author: 14 January 2020; Revised manuscript received: 24 January 2020; Accepted: 24 January 2020; Publication date: 25 February 2020.

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