FDA's position will impact what types of biosimilar and interchangeability applications can be submitted for insulin and other "deemed" protein products. Agency says in final Q&A guidance on transition provisions that the holder of a standalone BLA cannot reference its own product in an application for a bisoimilar or interchangeable version.
Less than three weeks before the regulatory transition of certain protein products to biologics, the US Food and Drug Administration is clarifying what types of biosimilar and interchangeability applications will and will not be permitted in the highly competitive insulin space after 23 March.
In a question-and-answer final guidance on the Biologics Price Competition and Innovation Act’s “deemed to be a license” provisions,...
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.
