Four of first 10 publicly disclosed applications were approved on first review cycle, and FDA has issued at least seven complete response letters. Increasing first-cycle approvals is a primary goal of the BsUFA II agreement.
Five years into the legislation that created FDA's biosimilar user fee system, a 40% first-cycle approval rate for publicly disclosed applications leaves ample room for progress under the program's next iteration.
While FDA has consistently met its Biosimilar User Fee Act (BsUFA) performance goals for reviewing and acting on a set...
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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.
