Senate health committee chair Lamar Alexander (R-TN) led a group of Republican senators in expressing anxiety about unresolved questions concerning FDA's implementation of the biosimilar pathway, saying the agency's “failure” to resolve fundamental questions -- such as naming -- before approving the first biosimilar last month “raises a number of serious concerns.” The senators especially take aim at FDA's authority around using a “placeholder” name for the first biosimilar approved in March.
The lawmakers say: “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.”
Alexander was joined by Republican Sens. Michael Enzi (WY), Richard Burr (NC), Johnny Isakson (GA), Mark Kirk (IL), Orrin Hatch (UT), Pat Roberts (KS) and Bill Cassidy (LA).
The lawmakers especially question FDA's use of a “placeholder” name for the first approved biosimilar -- Sandoz's filgrastim drug product, which carries the placeholder name filgrastim-sndz.
“It is unclear to us what it means for a nonproprietary name to be a 'placeholder,' what authority FDA has to make such a designation, or what treatment a 'placeholder' name will receive once FDA formalizes a naming policy,” they say. “In addition, we are concerned that hospitals, consumers, patients, doctors, and others may be confused by a name that appears temporary or not fully approved.”