FDA's user fee deal with sponsors sets target dates for documents on interchangeability, naming and labeling, but non-industry stakeholders urge agency to accelerate their release; guidance development efforts will get boost in BsUFA II with funding for new dedicated biosimilars unit starting in fiscal year 2018.
The FDA/industry-negotiated agreement to renew the biosimilar user fee program provides too much lag time for issuing and finalizing key guidance documents, representatives from consumer and professional groups said at an Oct. 20 meeting.
However, the agreement’s target dates for a long-delayed draft guidance on interchangeability, and final guidance documents on nonproprietary naming and...
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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.
