Janssen concludes the manufacturing processes for Renflexis do not infringe its Remicade patents, clearing Samsung and partner Merck from potential damages resulting from their at-risk launch of the biosimilar; innovator's legal action remains against Inflectra partners Pfizer and Celltrion.
Janssen Biotech Inc.'s dismissal of its suit against Samsung Bioepis Co. Ltd. is good news for biosimilar sponsors as it shows they can defeat claims that their manufacturing processes infringe an innovator's patents.
Janssen dropped the complaint on Nov. 10, two days after a district court judge agreed to extend the deadlines for...
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.
