Today, the Food and Drug Administration (FDA) announced new draft guidance to fast-track approval and adoption of biosimilars by eliminating comparative clinical efficacy study requirements, also known as switching studies, for biosimilar drugs. ASHP has long advocated to eliminate these switching studies that delay approval of biosimilars.
The FDA also indicated that it would like to recognize all biosimilars as interchangeable, another recommendation advocated by ASHP.
If biosimilars are treated as interchangeable with their reference products, it will expand the ability of pharmacists, in collaboration with their healthcare teams, to substitute low-cost biosimilars. FDA’s stated goal is to double or triple the number of biosimilars approved.
“This is a commonsense step that will speed up approval, providing patients and providers with more access to lower-cost biologics,” said Tom Kraus, ASHP vice president of government relations. “We will continue to urge Congress to act to make all biosimilars interchangeable and ease other restrictions, like patent manipulation and thickets, that impede biosimilar availability.”
ASHP is currently reviewing and analyzing the draft guidance’s potential impacts on biosimilar substitution and approval. It is also important to note that FDA guidance is nonbinding, so these changes may not immediately take effect.
