Reuters: Regulatory News: UPDATE 1-FDA approves Teva copycat of Amgen's Neupogen

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UPDATE 1-FDA approves Teva copycat of Amgen's Neupogen Aug 29th 2012, 21:31 Wed Aug 29, 2012 6:04pm EDT * Drug boosts white blood cells * Teva drug is similar to Amgen's Neupogen WASHINGTON Aug 29 (Reuters) - U.S. drug regulators gave the nod to a Teva Pharmaceutical Industries drug that boosts the production of infection-fighting white blood cells in certain cancer patients receiving chemotherapy. Teva's medicine is similar to Amgen Inc's biologic drug Neupogen, which faces the expiration of its U.S. patent next year. "While approval at this time is somewhat unexpected, we note the two drugs are not substitutable, and it will require a launch ramp and extensive marketing efforts by Teva to gain share," RBC Capital Markets analyst Michael Yee said in a research note. Amgen's U.S. sales of Neupogen was $959 million last year. Sales of Neulasta, the biotech company's longer-lasting white blood cell booster, were $3 billion in 2011. In a settlement of patent litigation, Teva agreed last year to refrain from launching its versions of both drugs in the United States until November 2013. Teva already sells its version of filgrastim in the European Union, where Yee said it accounts for about 5 percent of the overall market. The U.S. Food and Drug Administration said Teva's drug, called tbo-filgrastim, stimulates the bone marrow to increase production of white blood cells, which may help cancer patients recover more quickly from the side effects of chemotherapy. Biotech drugs, which are derived from living organisms such as proteins, are usually given by injection. The innovative drugs - first introduced in the 1980s - can cost tens of thousands of dollars a year. Copying them, while ensuring safety, is much more complicated, and expensive, than duplicating conventional chemical-based compounds. Generic drugmakers like Israel-based Teva are pushing into the field of biosimilars as global pharmaceutical companies face the loss of patent protection on many established drugs. Link this Share this Digg this Email Reprints

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