Interchangeability – Safe Biologics

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Interchangeability and Physician Notification

Patients and Physicians Want Doctors Involved in Treatment Decisions. ASBM One Pager on Automatic Substitution.

ASBM Statement on Automatic Substitution

As ASBM works with stakeholders to develop an official position statement on automatic substitution, there are a few key principles that ASBM believes must be reflected in any policy recommendation.
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National Advisory Board Convene on Physician Notification

ASBM Chairman Dr. Richard Dolinar convened a working group of Advisory Board members on May 24, 2012 to discuss the elements of a physician notification policy for biosimilars that prioritizes patient safety.
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ASBM Article on Biosimilars and Interchangeability

Dr. Dolinar wrote an article for May edition of the BIO Newsletter that discusses Interchangeability.
Read Biosimilars Ahead, Proceed with Caution

State Legislation

Read more on state legislation on interchangeability on our Policy Resources page.

Presentation: A Framework to Ensure Safe Substitution

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Latest News

April 2024 Newsletter

ASBM’s Michael Reilly: Preserve the US Interchangeable Standard that Has Helped Drive Physician and Patient Confidence in Biosimilars In an April interview with EndpointsNews, an FDA official called on Congress to eliminate the distinction between biosimilars (which can be prescribed in place of their reference products by a physician) and “interchangeable” biosimilars, which can be substituted by pharmacists the […]

March 2024 Newsletter

Biden Administration HHS Budget Would Permit Third-Party Substitution of All Biosimilars On March 11th, the Biden Administration released its FY25 HHS Budget. In response, ASBM Executive Director Michael Reilly published a blog post sharing his concerns with the Administration’s proposal to permit widespread automatic (pharmacy-level) substitution of all biosimilars in place of their reference products; without physician approval […]

ASBM’s Michael Reilly: Preserve the US Interchangeable Standard that Has Helped Drive Physician and Patient Confidence in Biosimilars

In an April interview with EndpointsNews, an FDA official called on Congress to eliminate the distinction between biosimilars (which can be prescribed in place of their reference products by a physician) and “interchangeable” biosimilars, which can be substituted by pharmacists the way generics are. Doing so would undermine physician confidence in biosimilars and jeopardize treatment stability for many […]