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Novartis wins landmark approval for a biosimilar of Amgen:  Novartis will be the first to hit U.S. shores with a copy of a blockbuster biotech drug, winning FDA approval for its take on Amgen's Neupogen and heralding a new era in biopharma.  Url:

Neupogen (Filgrastim) Drug Information: Description, User ...:  NEUPOGEN (filgrastim) is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. NEUPOGEN is produced by Escherichia coli (E coli) bacteria into which has been inserted the??...  Url:

Amgen motion to delay Neupogen biosimilar denied ...:  Amgen, which markets Neupogen, hoped to push this date back even further. Zarxio is the biosimilar of Neupogen. Amgen argued that ???it would suffer irreparable harm from 'immediate and irreversible price erosion'??? if Sandoz??...  Url:

Amgen fails to block Novartis' Neupogen biosimilar ...:  Novartis made history this month with the first FDA approval of a biosimilar, and now a judge's ruling has cleared the way for its launch. The drug, Zarxio, is a copy of Amgen's blockbuster Neupogen, which is designed to boost??...  Url:

Analyst: 'Mess Continues' With Amgen Neupogen Competitor:  Amgen, Inc. (NASDAQ: AMGN) will face competition for its Neupogen chemotherapy treatment from biotechnology, but exactly when a newly approved rival comes to market, and at what price, remains uncertain, an analyst??...  Url:

FDA Law Blog: Denied! District Court Rules in NEUPOGEN ...:  District Court Rules in NEUPOGEN Biosimilar Litigation; Says that the BPCIA's ???Patent Dance??? Procedures are Optional, and Notice Can Come Before Commercial Marketing. By Kurt R. Karst ???. Hopes for a victory were??...  Url:

Amgen, Inc. Files Petition To Stop Novartis (NVS) From ...:  Amgen Inc (NYSE: AMGN) is seeking a preliminary injunction against Sandoz, a subsidiary of Novartis AG ADR (NYSE: NVS) over its application for the biosimilar copy of Amgen's blockbuster drug, Neupogen, for the??...  Url:

Novartis gets bragging rights on first U.S. biosim. But will its ...:  It's been a long, long regulatory road, but the first FDA-approved biosimilar--a copy of Amgen's Neupogen from Novartis' generics unit, Sandoz--is finally here. But that doesn't mean it'll catch on right away, as the Swiss??...  Url:

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