FDA Issues Final Guidance on Biosimilar Interchangeability

The U.S. Food and Drug Administration (FDA) released guidelines on the studies companies need to conduct to show their biosimilar is interchangeable with a biologic. Currently, biosimilars can’t automatically be substituted by a pharmacy for a brand product without FDA’s interchangeability designation. And, while there are 24 approved biosimilar drugs (as of this writing), there are no FDA-approved interchangeable biosimilars on the market. This is because while federal law created a pathway for interchangeability, drug companies have been seeking greater guidance from FDA.

“Today’s final guidance gives an overview of important scientific considerations in demonstrating interchangeability with a reference product, and explains the scientific recommendations for an application or a supplement for a proposed interchangeable product,” said acting FDA Commissioner Ned Sharpless.

The guidance is part of a larger action plan by FDA to spread biosimilar use. Currently, only one company, Boehringer Ingelheim, is pursuing FDA approval for an interchangeable biosimilar for the arthritis drug Humira, one of the top-selling drugs in the world.

The guidance document can be downloaded at www.fda.gov/media/124907/download.