Genentech seeks court order requiring Amgen to provide biosimilar manufacturing info so it can evaluate potential infringement; Supreme Court to hear Zarxio case on April 26.
In a new twist to biosimilar litigation, Genentech Inc. contends that Amgen Inc. cannot opt out of providing manufacturing process information for its biosimilar to Genentech's monoclonal antibody Avastin (bevacizumab) once it begins the exchange of patent information, known as the "patent dance."
Genentech, a unit of Roche, filed suit in Delaware District Court on Feb. 15 seeking a declaratory...
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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.
