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UPDATE 1-FDA to review Teva biosimilar of Amgen's Neupogen
February 2, 2010 / 4:44 PM / 8 years ago

UPDATE 1-FDA to review Teva biosimilar of Amgen's Neupogen

* FDA accepts filing of biosimilar to be called Neutroval

* Teva shares up 1.4 pct, Amgen shares off slightly

NEW YORK, Feb 2 (Reuters) - Generic drugmaker Teva Pharmaceutical Industries Ltd (TEVA.TA) said on Tuesday the U.S. Food and Drug Administration will review its application to sell a biotechnology medicine to boost white blood cells that is similar to Amgen Inc’s (AMGN.O) big-selling Neupogen.

Teva said the FDA accepted its Biologics License Application for the medicine for which it has proposed the trade name Neutroval.

The Teva drug, XM02, is already being sold under the name TevaGrastim in several European countries, where a pathway for approving generic versions of biotech drugs -- so-called biosimilars -- is already in place.

No such pathway for generic biotech medicines exists yet in the United States. The U.S. Congress has been weighing creation of a process for companies to seek approval of generic biotech medicines as part of stalled healthcare reform legislation.

In the absence of a U.S. route to generic biotech drugs, Teva said in December that its FDA application treats XM02 as a new biotech medicine.

The Teva drug, like Amgen’s Neupogen, is used to boost white blood cells in cancer patients undergoing some types of chemotherapy that can cause severe neutropenia, or low white blood cell count.

Amgen, which has not yet had to face any generic competition for its medicines in the United States, reported combined worldwide sales of $4.64 billion in 2009 for Neupogen, known chemically as filgrastim (G-CSF), and a related medicine Neulasta.

Teva shares were up 79 cents, or 1.4 percent, at $57.45 on Nasdaq, while Amgen shares were off 4 cents to $58.68 also on Nasdaq. (Reporting by Bill Berkrot; edited by Gunna Dickson)

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