Apotex's Neulasta, Neupogen Biosimilars Clear Legal Hurdles, But Approval Questions Remain

 
• By Brenda Sandburg

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.

Court of Appeals for Federal Circuit Lafayette Park Across from White House Washington DC
US Court of Appeals for the Federal Circuit rules in favor of Apotex on Amgen's infringement claims.

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