Specialty Pharma Journal Specialty, Precision & Technology
Amgen has temporarily blocked Sandoz’s Zarxio, the biosimilar version of Amgen’s Neupogen. The US Court of Appeals for the Federal Circuit in Washington has granted Amgen’s request for an injunction to stop the company from selling the drug in the US until the Court resolves the appeal. Additionally, the order …
Tag Archives: neupogen
May, 2015
March, 2015
-
20 March
Judge Rejects Amgen’s Effort to Block Sandoz Biosimilar Version of Neupogen
A federal judge denied Amgen Inc.’s effort to block the sale of Sandoz’s recently approved biosimilar version of Neupogen. U.S. District Judge Richard Seeborg in San Francisco on Thursday rejected Amgen’s bid for a preliminary injunction blocking Novartis’ Sandoz from selling its Zarxio (filgrastim), a biosimilar version of Amgen’s Neupogen …
-
6 March
FDA Approves Sandoz Zarxio as First Biosimilar in the US Market
Sandoz, a Novartis company, is the first company to receive approval of a biosimilar in the US through the new biosimilars pathway. The US Food and Drug Administration (FDA) approved Sandoz’s Zarxio (filgrastim-sndz) for all indications included in the label of the reference product, Neupogen. Amgen’s Neupogen (filgrastim) was originally …
January, 2015
-
8 January
FDA Panel Recommends Approval of Sandoz’s Biosimilar Version of Neupogen
A panel of advisors for the US Food and Drug Administration (FDA) has recommended approval of Novartis’ investigational biosimilar version of Amgen’s Neupogen (filgrastim). The agency’s independent Oncologic Drugs Advisory Committee (ODAC) voted 14-0 in favor of approving Novartis’ biosimilar version of Amgen’s cancer drug Neupogen, which boosts white blood …