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FDA Panel Approves Drug to Compete With Amgen’s Neupogen

A U.S. Food and Drug Administration advisory panel on Wednesday unanimously recommended the agency approve a “biosimilar” version of Amgen Inc.’s cancer drug Neupogen. Neupogen had global sales of $5.8 million in 2013 but its U.S. patent expired in December. The drug stimulates production of white blood cells in bone marrow and is given to patients undergoing radiation or chemotherapy, which depletes white cell counts. The copycat drug from Novartis AG, called Zarxio, would be the first biosimilar drug to receive FDA approval. Biosimilars are medicines that copy proprietary biotech drugs when patent protection expires. Because small differences in environment or manufacturing processes may alter the final product, the drugs are called similar – but not identical – to the original drug. The panel recommended Zarxio be approved for the same five conditions that Neupogen treats. The FDA will give final approval for Zarxio in March, but the agency nearly always follows the recommendation of its expert panels. Amgen shares closed up $5.34 or 3.5 percent to $158.24 on the Nasdaq.

Joel Russel
Joel Russel
Joel Russell joined the Los Angeles Business Journal in 2006 as a reporter. He transferred to sister publication San Fernando Valley Business Journal in 2012 as managing editor. Since he assumed the position of editor in 2015, the Business Journal has been recognized four times as the best small-circulation tabloid business publication in the country by the Alliance of Area Business Publishers. Previously, he worked as senior editor at Hispanic Business magazine and editor of Business Mexico.
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