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GEN News Highlights : Feb 13, 2009

Sandoz’ Biosimilar to Amgen’s Anemia Drug Gets EU Go-Ahead

Filgrastim obtained approval for the same range of indications as Neupogen.

Sandoz received the green light to market its biosimilar to Amgen’s neutropenia treatment, Neupogen®, from the European Commission. While the U.S. drags it feet in creating a path for follow-on biologic approval, the decision on Sandoz’ filgrastim marks the firm’s third EC sanction.
 
The Sandoz product is approved for the same range of indications as Neupogen and offers patients comparable quality, safety, and efficacy combined with greater cost-effectiveness. Sandoz also points out that its filgrastim needlestick protection device decreases the risks of injury and exposure to blood-born infection.
 
Sandoz won approval for the first biosimilar in the EU in April 2006, when its human growth hormone, Omnitrope®, was given the go-ahead. Erythropoetin Binocrit® and glycoprotein Epoetin followed suit in August 2007.
 
Teva Pharmaceutical already has a version of Neupogen on the market in the EU. The drug was developed with Ratiopharm.

 

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