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Biosimilar Barricade Breached: Amgen Manufacturing Patents Ruled Not Infringed

 
• By Brenda Sandburg

Apotex's Neulasta and Neupogen biosimilars do not infringe Amgen's patent, showing sponsors can get around innovator's manufacturing process patents.

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Apotex Inc. has eliminated a legal roadblock to launching its biosimilars to Amgen Inc.'s Neulasta (pegfilgrastim) and Neupogen (filgrastim) but still has to convince FDA to clear its applications.

Judge James Cohn of the US District Court for the Southern District of Florida ruled that Apotex's biosimilar candidates do not infringe Amgen's manufacturing process patent, No. 8,952,138, which covers a process of protein refolding

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