The World Health Organization is making inroads into its plan to prequalify biosimilars, starting with a pilot project involving two anti-cancer medicines. It has developed two assessment pathways to prequalify biosimilars, depending on whether not these products are already approved by a stringent regulatory authority. During the pilot phase, the fees associated with prequalification will be waived.
The World Health Organization is inviting stakeholder feedback on the procedure it plans to follow and the data it would require for prequalifying biosimilar versions of certain anti-cancer drugs free of charge, as part of a pilot project to be launched in September.
This is the first time that the WHO is looking into prequalifying biosimilars, and the first products on the list...
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.
