Amgen’s manufacture in California of its biosimilar for the European market infringes three recently issued patents, says Coherus, which is considerably behind Amgen in developing its own copy of AbbVie’s Humira. Lawsuit highlights the key role that intellectual property is likely to play in protecting biosimilar formulations, one patent attorney says.
Although Amgen Inc. appears primed to get a 10.5-month head start over Coherus BioSciences Inc. in the US biosimilar adalimumab market come 2023, Coherus is seeking to leverage three new patents to get a piece of Amgen’s European biosimilar revenue now.
On Jan. 24, Coherus sued Amgen in US District Court for the District of Delaware, alleging the latter’s manufacture in...
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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.
