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323915183

Substitution Policy

Backgrounders


Backgrounder: Interchangeability and Substitution
Backgrounder: Indication Extrapolation

In the States

Latest News

ASBM Submits Comments on Health Canada’s Biosimilar Handbook for HCPs

On April 29th, ASBM submitted comments to Health Canada as part of a stakeholder consultation on its draft Handbook for healthcare professionals on biosimilar biologic drugs. One key area of focus for ASBM’s comments was mixed messaging surrounding biosimilar equivalence and switching, including language which implies, inaccurately, that Canada’s policies were consistent with those of regulators in […]

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VA Study: Patients Switched to Biosimilar Infliximab More Likely to Stop Treatment

On February 18th, a study was published in the journal Current Medical Research and Opinion, which examined US Veterans Healthcare Administration (VHA) patients who were switched from innovator infliximab to the VHA-preferred biosimilar. The study found that those who were switched from the reference product to the biosimilar were almost 3 times more likely to stop treatment and 5 times more likely […]

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ASBM Video Shares US Physician Perspectives on Non-Medical Switching

ASBM has released our latest video, “Non-Medical Switching”, featuring ASBM Chairman Ralph McKibbin, MD. In the video, Dr. McKibbin shares new data from ASBM’s recent survey of 401 U.S. prescribers of biologics, as well as his own observations on the controversial practice. Among the survey findings: 69% of US physicians surveyed consider it “very important or critical” […]

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The Alliance for Safe Biologic Medicines is an organization composed of diverse healthcare groups — from patients to physicians, medical innovators, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

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Who we are
  • About Us
  • Leadership
  • Member Partners
  • International Advisory Board
News
  • Latest News
  • Letters
  • Newsletter
  • Press Releases
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The Issue
  • About the Issue
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  • Naming
  • Substitution Policy
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  • BIO Principles
Policy
  • Australia
  • Canada
  • European Union
  • FDA
  • FDA Guidance
  • In the States
Resources
  • Surveys
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