Biosimilars: FDA Casts Wide Net For Creation Of User Fees
This article was originally published in The Pink Sheet Daily
Agency seeks "consultation meetings" with patient, consumer, professional and academic groups as it develops congressionally-mandated report on the nascent approval pathway.
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As negotiations about the next user fee cycle continue, FDA is offering an opportunity for sponsors to formally discuss an application's progress with reviewers, although it appears the new proposed meeting would come too early in the process for industry’s satisfaction.
FDA appeared to be searching for a way to limit the clinical trial requirements for biosimilars during a two-day public hearing on implementing a pathway for the products.
The generic industry largely rejects one of the theoretical structures floated by FDA for an ANDA user fee program: paying more for reviews of complex drugs. But the concept does have support from many consumer advocates and at least one member of the Generic Pharmaceutical Association's board of directors, suggesting that the approach might continue to guide regulatory thinking even if it is not part of the final deal between industry and the agency.