Regulators and doctors must work together to ensure safety of biologic medicines

By Dr. Marcy Zwelling-Aamot, chairperson of the Board of the American Academy of Private Physicians (AAPP)
The Hill

The U.S. Food and Drug Administration (FDA) is holding an important public meeting today on its proposed biosimilar user fee program recommendations. This meeting is a major step in making biosimilars available for the first time in the United States. Biosimilars will benefit the patient community-at-large – but only if important safety measures are adopted.

Biosimilars are the lower cost imitative versions of biological medicines, which are advanced therapies made in living systems. These cutting-edge medicines treat non-Hodgkin’s lymphoma and several other cancers, Hepatitis C, and even Multiple Sclerosis. Over 350 million patients worldwide have benefited from approved biologic medicines, and over 650 new biologic medicines and vaccines are being developed to treat more than 100 diseases, yet there are no “biosimilar” versions of these products available in the United States.

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 […]