FDA's Biosimilar Suffix 'Error': Molehill Withdrawn But Mountain Coming?
Executive Summary
While FDA may envision suffix selection to be simple, sponsors and branding firms see a much more involved process.
You may also be interested in...
Biological Product Suffix Submissions Limited To 10 Candidates By US FDA
Increasing cap on number suffixs that sponsors can submit from three to 10 will increase review efficiency, agency says, but evaluation will still stop after finding first acceptable suffix as part of final guidance on distinguishable nonproprietary names for novel biological products and biosimilars.
Biological Product Suffix Submissions Limited To 10 Candidates By US FDA
Increasing cap on number suffixs that sponsors can submit from three to 10 will increase review efficiency, agency says, but evaluation will still stop after finding first acceptable suffix as part of final guidance on distinguishable nonproprietary names for novel biological products and biosimilars.
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.