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FDA accepts Sandoz's BLA for filgrastim biosimilar

July 24, 2014 11:55 PM UTC

Sandoz, a unit of Novartis AG (NYSE:NVS; SIX:NOVN), said FDA accepted a BLA for a biosimilar version of Neupogen filgrastim G-CSF from Amgen Inc. (NASDAQ:AMGN). Sandoz is the first company to announce FDA's acceptance of a biosimilar application.

Sandoz's filgrastim biosimilar is marketed as Zarzio in more than 40 countries, is the "number one biosimilar filgrastim globally and is the leading daily G-CSF in Europe with 30% volume market share," according to the company. ...