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. 2017 Mar;23(3):266.
doi: 10.18553/jmcp.2017.23.3.266.

Letter--Draft FDA Guidance "Considerations in Demonstrating Interchangeability with a Reference Product": Overview and Presentation-Related Concerns

Elan Rubinstein  1
Affiliations

Letter--Draft FDA Guidance "Considerations in Demonstrating Interchangeability with a Reference Product": Overview and Presentation-Related Concerns

Elan Rubinstein. J Manag Care Spec Pharm. 2017 Mar.

Abstract

Rubinstein provides consulting services to the pharmaceutical industry, health plans, employers, and specialty pharmacies, and is a member of the editorial advisory board of Specialty Pharmacy News. He was a participant on the Amgen Biosimilar Report Advisory Board and reports consulting fees from Amgen.

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Conflict of interest statement

Rubinstein provides consulting services to the pharmaceutical industry, health plans, employers, and specialty pharmacies, and is a member of the editorial advisory board of Specialty Pharmacy News. He was a participant on the Amgen Biosimilar Report Advisory Board and reports consulting fees from Amgen.

References

    1. U.S. Food and Drug Administration.. Considerations in demonstrating interchangeability with a reference product. Guidance for industry. Draft guidance. January 2017. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati.... Accessed February 9, 2017.
    1. Ropes & Gray.. FDA issues draft guidance on biosimilar interchange-ability. FDA regulatory alert. January 27, 2017. Available at: https://www.ropesgray.com/newsroom/alerts/2017/01/FDA-Issues-Draft-Guida.... Accessed February 9, 2017.
    1. Latham & Watkins.. FDA issues draft guidance on biosimilar interchange-ability. Client Alert Commentary. January 27, 2017. Available at: https://www.lw.com/thoughtLeadership/LW-FDA-issues-guidance-on-biosimila.... Accessed February 9, 2017.
    1. Submit electronic comments at: https://www.regulations.gov. Reference name of draft guidance and Docket No. FDA-2017-D-0154.
    1. U.S. Food and Drug Administration.. Information on biosimilars. Updated May 10, 2016. Available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDeveloped.... Accessed February 9, 2017.

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