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FDA's Biosimilar Suffix 'Error': Molehill Withdrawn But Mountain Coming?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.

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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.

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