Teva seeks approval for biosimilar filgrastim in U.S.

2/19/2009

NEW YORK The world’s largest maker of generic drugs wants to get approval for a biosimilar, according to published reports.

Teva Pharmaceutical Industries may try to win approval for a biosimilar of Amgen’s immune-boosting drug Neupogen (filgrastim), company executives said Wednesday, according to Reuters.

Teva’s biosimilar filgrastim is approved in Europe. If Teva seeks approval for the United States market, it will have to file the same type of application that it would if it were making a novel biotech drug.

Neupogen had U.S. sales of $896 million last year, according to Amgen financial reports.

Dr. Reddy’s Labs and Sandoz also make biosimilars of filgrastim.

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