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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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.
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.
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.