Biosimilar User Fee Agreement Puts FDA On Hook For Delayed Guidances
Draft guidelines on interchangeability and statistical considerations due by end of 2017, suggesting long-awaited documents may not see the light of day this year as many had hoped.
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Biosimilar User Fee Agreement Offers FDA Funding Boost, Fee Structure Overhaul
BsUFA revenue amounts and fees will be separated from PDUFA and relative contribution of each fee type to the overall pot will change; user fee revenue target for program's first year is $45m.
FDA Biosimilar Policy Continues To Evolve With Approval Of Sandoz Erelzi
Third biosimilar approved in US brings another iteration of FDA thinking on labeling and naming; etanercept-szzs, which references Amgen's Enbrel, suggests agency might be backtracking on its suffix policy.
Biosimilar Labeling: Should FDA Just Throw Up Its Hands And Finalize Guidance?
Brand and generic industries are on opposite sides of spectrum on most issues; there is mutual opposition, however, to the use of a meaningless four-letter suffix in the proper name of a product.