Updated interchangeability guidance is one of several 'incremental reforms' agency is working on that could ease development burden for biosimilars, Commissioner Scott Gottlieb says.
The US FDA will make its draft requirements for demonstrating the interchangeability of biosimilars and their reference biologic less burdensome to help stimulate development of follow-on products, Commissioner Scott Gottlieb said at an April 19 policy conference sponsored by the Pharmaceutical Care Management Association.
The agency is working on a "suite of policies aimed at making incremental gains in trying to facilitate market entry...
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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.
