Suffix Smackdown: Gottlieb Calls Issue 'Red Herring' For Biosimilars
'This is important for our own pharmacovigilance,' US FDA commissioner says. 'We still have an open question on whether or not we’re going to apply a suffix or change also the branded company’s name as well.'
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US FDA's biosimilar chief tells Pink Sheet that sponsors will receive more advice specific to their development programs based on their data package, a practice already in use in some cases.
Sponsors may have to rely even more on the advice they receive from formal meetings as FDA decides to rewrite draft guidance on statistical approaches to evaluate analytical similarity for biosimilars.
Proposed change was aimed at protecting monograph-covered products subject to March 2020 'transition provisions,’ but agency’s objections went to the heart of the monograph system; other stakeholder groups said proposed change would amount to an endorsement of FDA's flawed and unjustified suffix-based naming system for biologics.