There’s been plenty of hand-waving in Washington about bringing generic versions of biotech drugs to market in this country. But rather than wait for all that to get worked out, Teva, the Israeli generics giant, went ahead and ran clinical trials on a biotech drug that’s a whole lot like Amgen’s Neupogen, a $900 million drug used to stimulate the growth of white blood cells.
The FDA has agreed to take a look at Teva’s application. But, as Dow Jones Newswires notes, Teva and Amgen are also duking it out in court, with Amgen arguing that the Teva drug infringes on an Amgen patent.
The case brings to mind the long, colorful court battle between Amgen and Roche over Roche’s Mircera, an anemia drug that a court ruled infringed on Amgen’s patents. Mircera never made it to market in this country.
Even if Teva’s Neupogen-like drug were to make it to the U.S. market, it would face some tough circumstances. For one thing, unlike traditional generics, it wouldn’t be substitutable — doctors would have to write a prescription for the Teva drug, Dow Jones Newswires notes. For another, Neupogen itself has been losing market share to Neulasta, Amgen’s longer-acting version of the drug.
Image: iStockphoto
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