
Court Blocks First FDA-Approved Biosimilar, for the Time Being
The US Court of Appeals granted Amgen’s request to block Novartis’ Neupogen biosimilar, Zarxio, from the US market until the court resolves litigation between the two companies.
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Sandoz agreed to delay sales of Zarxio in the US after it was approved due to the ongoing legal battle with Amgen. Amgen alleged that Sandoz failed to supply Amgen with manufacturing information and a biologics license application (BLA) within 20 days of FDA acceptance, something that it says is US regulatory policy. A US District Judge in San Francisco
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