Final guidance adds new factors for biosimilar and innovative sponsors to consider in developing distinguishable suffixes for nonproprietary names but FDA is unswayed by calls for meaningful suffixes derived from license holder’s name; timing of retrospective application to previously approved products remains in question.
FDA’s final guidance on nonproprietary naming gives biosimilar developers and innovative biologic product sponsors more clarity on how four-letter suffixes will be evaluated for distinguishable nonproprietary names, but it also leaves a wake of questions about how the agency will implement this policy across a large swath of approved products.
The agency is sticking with its plan to require that distinguishable suffixes devoid of meaning be added to the nonproprietary...
We’ve all been told that walking 10,000 steps a day is the magic number for better health. But what if the real secret to walking more isn’t about counting steps at all? In this article, we explore how focusing on motivation, environment, and mindset can help you build a walking habit that lasts.
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.
