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Neupogen (Filgrastim) Drug Information: Description, User ...:  Filgrastim is a human granulocyte colony-stimulating factor (G-CSF)??? produced by recombinant DNA technology. NEUPOGEN?? is the Amgen Inc. trademark for Filgrastim??? which has been selected as the name for recombinant methionyl??...  Url: http://www.rxlist.com/script/main/hp.asp

FDA reviewers back Novartis biosim of Amgen's blockbuster ...:  Those looking for a window into the FDA's thoughts on biosimilars got their first direct peek Monday. The agency released briefing documents for an upcoming panel meeting on Novartis' biosimilar of Amgen's Neupogen.  Url: http://www.fiercepharma.com/news

Amgen-Sandoz squabble over Neupogen copy could ...:  In fact, as a lawsuit over Sandoz's knockoff version of the Amgen ($AMGN) therapy Neupogen shows, the two sides don't even agree on the rules. Here's the background. Sandoz, the Novartis ($NVS) generics unit, filed for??...  Url: http://www.fiercepharma.com/news

FDA Panel Backs Novartis AG Biosimilar Of Amgen's ...:  An advisory panel to the FDA unanimously supported the approval of Novartis AG (ADR)'s (NYSE:NVS) investigational biosimilar version of Amgen's cancer drug Neupogen, paving way for the introduction of cheaper??...  Url: http://www.bidnessetc.com/

Novartis clears an FDA hurdle with its pioneering biosimilar ...:  If the injection wins approval, Novartis would be able to cut in on the roughly $1.4 billion Amgen made on Neupogen last year. And the drug, already marketed as Zarzio by Novartis' Sandoz unit in more than 40 countries,??...  Url: http://www.fiercebiotech.com/news

Novartis' Biosimilar of Neupogen Gets Favorable Opinion ...:  The positive recommendation was provided on the basis of comprehensive nonclinical, clinical and post-marketing pharmacovigilance data, which confirmed that Sandoz' biosimilar version is highly similar to Neupogen.  Url: http://www.zacks.com/

Novartis rolls toward FDA nod with a copy of Amgen's ...:  Novartis' copy of Amgen's top-selling Neupogen matched up well with the original, FDA reviewers said, recommending what would be the first U.S. approval of a biologic knock-off.  Url: http://www.fiercebiotech.com/news

FDA Law Blog: Novartis's Biosimilar of Neupogen Clears a ...:  By James C. Shehan ??? FDA's Oncologic Drugs Advisory Committee unanimously voted in favor of approval of EP2006, Novartis's biosimilar version of Amgen's Neupogen?? (filgrastim) for all five of the indications for which??...  Url: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/



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