US Senators call for immediate release of guidance on biosimilar drugs

US Senators Lamar Alexander (Republican, Tennessee) and Orrin Hatch (Rep, Utah) have led colleagues in calling on the Obama administration to release guidance documents on biosimilar drug approvals.

The senators were joined by three Republican members on the Senate health committee, Senators Richard Burr (North Carolina), Mike Enzi (Wyoming) and Pat Roberts (Kansas).

In a letter to Health and Human Services Secretary Sylvia Burwell, the senators write: “We write today with concerns about the implementation of the Biologics Price Competition and Innovation Act (BPCIA), bipartisan legislation enacted in 2010 to provide the US Food and Drug Administration (FDA) with a framework to review and approve biosimilars. The FDA has not yet issued guidance on some of the key scientific policy questions related to biosimilars, such as naming, labeling, indication extrapolation, and interchangeability.”