Tweet This

Biosimilars User Fee Act

Creates an abbreviated licensure pathway for biologic products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biologic product. This pathway is provided in the part of the law known as the Biologics Price Competition and Innovation Act (BPCI Act).

Food and Drug Administration (FDA)

Agency under the U.S. Department of Health and Human Services that regulates the approval of all new drugs, biologics and medical devices as well as…