by Amanda Conschafter, blog editor
The Food and Drug Administration’s distinct name for the first biosimilar was a “placeholder,” the agency declared on March 6. But the approach may also have been “confusing,” “opaque” and unsafe for patients, according to an April 30 letter to the FDA from Senate Health Committee members.
While the senators praised FDA for releasing its first final guidance last week, they also urged the agency to answer more fundamental questions to make the biosimilar pathway “a successfully functioning one.” In particular, the senators emphasized the need for clear guidance on interchangeability, nonproprietary names and the production of patent information.
Regarding naming, the senators explained, “We are concerned that hospitals, consumers, patients, doctors, and others may be confused by a name that appears temporary or not fully approved.” They also questioned the very nature of a placeholder name and FDA’s authority to create one.
The senators raised concerns about labeling for biosimilar medications as well. “The first approved labeling for a biosimilar product…contains no statement regarding the product’s interchangeability status. Indeed, the label does not even include the word ‘biosimilar,’ which could further increase consumer confusion about how this product relates to the reference biologic,” they noted.
Beyond specific criticisms, the senators questioned the FDA’s process – such as providing much of the available guidance in draft form only and approving the first biosimilar before answering fundamental questions about regulation and safety.
Given the “troubling degree of uncertainty” fostered by FDA’s approach thus far, Health Committee members requested clarification from the FDA on a series of questions, which encompass the role of transparent labeling, the future of “placeholder” names, the timeline for forthcoming guidance on interchangeability and FDA’s efforts to educate patients.
The senators have requested a response from the FDA by May 22.