Senate Health Committee leaders call for FDA to finalize guidance on biosimilar drugs

U.S. Sen. Lamar Alexander (R-TN), along with nine other fellow Republican legislators on the Senate Health Committee, urged the U.S. Food and Drug Administration on Thursday to immediately finalize and provide all guidance for biosimilar drugs.

Sens. Michael Enzi (R-WY), Richard Burr (R-NC), Johnny Isakson (R-GA), Mark Kirk (R-IL), Orrin Hatch (R-UT), Pat Roberts (R-KS), Susan Collins (R-ME) and Bill Cassidy (R-LA) joined Alexander in signing a letter to Dr. Stephen Ostroff, FDA acting commissioner, demanding final guidance from the agency “on which the public can rely.”

The letter acknowledged the first final guidance on the biosimilar pathway, released earlier by the FDA, but stated, “FDA still has not provided guidance on many fundamental issues, and much of the guidance it has provided is in draft form. Resolving unsettled questions about the biosimilar approval pathway is critical to ensuring that patients have access to safe and effective biosimilars.”

“It is important to us that this pathway become a successfully functioning one, as Americans will benefit from greater competition and more treatment options,” the Senators continued. “FDA has not provided sufficient guidance on important issues relating to the review and approval of license applications for biosimilar products, such as naming, interchangeability, and production of patent information.”

The senators go on to explain that the FDA’s failure to provide answers to “fundamental science and policy questions” through final guidance in advance of the first biosimilar approval is cause for concerns. They also reiterated the need for final guidance for the FDA staff working to review the biosimilar applications.

“It is not clear what agency policies, if any, have been governing the process,” the letter states.

“The Biologics Price Competition and Innovation Act, passed over five years ago, was meant to foster competition and improve choices for American patients, and all of us want the biosimilars pathway it established to succeed,” the Senators wrote in conclusion. “However, FDA’s opaque implementation process is creating a troubling degree of uncertainty for patients, doctors, manufacturers, and other stakeholders who are invested in the success of this pathway.”