Federal appeals court affirms ruling that Apotex's biosimilars do not infringe Amgen's manufacturing process patent, but its applications have stalled at FDA for the past three years.
Apotex Inc. faces no current legal barriers to the launch of its biosimilars to Amgen Inc.'s Neulasta (pegfilgrastim) and Neupogen (filgrastim) now that the US Court of Appeals for the Federal Circuit has ruled they do not infringe Amgen's manufacturing process patent. But the fate of Apotex's applications at FDA remain uncertain three years after they were filed.
In a Nov. 13 decision, the Federal Circuit affirmed a district court ruling that Apotex's biosimilars do not...
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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.
