Apotex argues that biosimilar studies in healthy volunteers are not sufficient to show clinically meaningful differences with the reference product; Coherus says it believes its application is scientifically sound.
Three weeks before FDA is to take action on Coherus BioSciences Inc.'s Neulasta (pegfilgrastim) biosimilar application, Apotex Inc. has asked the agency to require all pegfilgrastim sponsors to conduct studies in the intended patient population, not just in healthy volunteers.
In an April 21 citizen petition, Apotex says FDA should require biosimilar sponsors referencing Amgen Inc.'s Neulasta...
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.
