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