ZURICH-Novartis AG NVS, +0.43% Thursday said it will begin selling the first bio similar drug in the U.S. after an appeals court in Washington rejected a request to block the Swiss drug maker's sale of its copycat version of Amgen Inc.'s blockbuster remedy, Neupogen.
Basel-based Novartis's move followed the decision Wednesday by the U.S. Court of Appeals for the Federal Circuit which has cleared the way for the firm's Sandoz unit to start selling Zarxio, a knockoff version of Neupogen that was approved by the U.S. Food and Drug Administration in March. The U.S. market accounted for more than 70% of Amgen's $1.16 billion in global sales of Neupogen last year, a drug for treating chemotherapy patients.
Zarxio was the first bio similar--a copy of a biotechnology drug--approved by the FDA under abbreviated criteria enabled by a provision of the 2010 Affordable Care Act. However the product's introduction has been delayed by a legal dispute between Amgen and Novartis.
Novartis hasn't announced a price for Zarxio. In Europe, where bio similars have been available for several years, they typically cost 15% to 30% less than the original brands.