'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.'
The US FDA’s guidance on biologics and biosimilar naming has been final for 18 months, but the agency continues to face implementation challenges as well as hear worries from stakeholders.
Commissioner Scott Gottlieb was asked during a July 18 address at the Brookings Institution to unveil the agency’s Biosimilar...
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The bispecific antibody is the latest example of a growing number of biologics receiving complete response letters related to third-party manufacturing facilities.
A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.
Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
