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(Bloomberg) -- The U.S. Supreme Court issued a mixed decision on the rules governing efforts to get low-cost alternatives to pricey biotechnology drugs on the market.
The justices said patent holders can’t use federal law to enforce a requirement that companies seeking to sell "biosimilars" provide information about their product. The unanimous court, however, said patent holders might be able to use state law to accomplish the same goal.
The case centered on an application by Novartis AG’s Sandoz unit to sell a copy of Amgen Inc.’s Neupogen, a white blood cell booster that’s been on the market since 1991. Sandoz began selling Zarxio, the first biosimilar of any drug in the U.S., in September 2015. Zarxio was approved for use in Europe in 2009.
The cases are Sandoz v. Amgen, 15-1039, and Amgen v. Sandoz, 15-1195.
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