Biosimilar drug makers say that the NOR-SWITCH study on switching from Johnson & Johnson’s infliximab to the Celltrion product supports the concept of biosimilarity and proves that they are subject to the same regulatory standards as originators. Originators, meanwhile, want more evidence that switching works.
Data from a landmark Norwegian study supporting biosimilars switching has fueled the debate over the nascent practice, with the biosimilar industry heralding the study’s significance and originators warning of its weaknesses.
The NOR-SWITCH study results, released on Oct. 18*, showed that physician-led switching from Johnson & Johnson’s originator infliximab, Remicade, to...
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.
