From the good folks at Inside Health Policy …
Senators Question FDA's Authority To Use 'Placeholder' Biosimilar Name
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.”
The senators ask FDA a series of questions regarding its implementation of the Biologics Price Competition and Innovation Act, including questions for clarification around what a “placeholder” nonproprietary name is, what the process is for changing such a name and the estimated economic impact of such a change.
They further ask what guidelines FDA staff members have been following in reviewing biosimilar applications, and whether staff members have been instructed to either follow or not follow recommendation in any of the draft guidance documents that FDA has published.
Additionally, the lawmakers inquire as to what circumstances FDA considers necessary for a biosimilar product to disclose in its labeling that it has or has not been found to be interchangeable with the reference product or other biosimilar products that share the same reference product. “Why did FDA (a) withdraw the draft guidance it published on this issue and (b) approve labeling for a biosimilar product that contains no such disclosure?” ask the senators.
They ask FDA to list the guidance documents regarding biosimilar or interchangeable products FDA currently intends to publish and on what timeline. FDA's drug center guidance agenda includes five planned guidances for 2015, including: additional questions and answers regarding implementation of the BPCIA; considerations in demonstrating interchangeability; labeling for biosimilar biological products; nonproprietary naming for biological products; and statistical approaches to evaluation of analytical similarity data to support a demonstration of biosimilarity.
The lawmakers also wonder why FDA has declined to provide guidance regarding whether the so-called patent dance provisions in the pathway are mandatory. A court decision out of the U.S. District Court for the Northern District of California last month ruled that the provisions were optional. The case is now on appeal and set to be heard June 3.
Finally, the lawmakers what to know how FDA is communicating with and educating patients in regards to biosimilars, including issues such as biosimilarity, extrapolation and interchangeability.
“We also urge FDA to prioritize the publication of final guidance on the issues identified above, and to improve the transparency of its biosimilar review and approval process going forward,” state the senators.