Amgen seeks declaratory judgement that its biosimilar Mvasi does not infringe 27 Genentech patents, has Genentech suit put under seal; Amgen gave 180-day commercial marketing notice on Oct. 6.
Three weeks after FDA approved Amgen Inc.'s biosimilar to Genentech Inc.'s Avastin (bevacizumab), the companies have launched opposing suits against each other. Amgen is seeking a declaratory judgment that its product Mvasi (bevacizumab-awwb) does not infringe 27 patents related to Avastin while Genentech is claiming infringement.
Amgen's suit is unusual in the young annals of biosimilar litigation in that it's the sponsor of the follow-on product,...
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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.
