Novartis AG said it would begin selling the first biosimilar drug in the United State after an appeals court denied Amgen Inc's request to block the Swiss drug maker's sale of its copycat version of blockbuster remedy NEUPOGEN.
Novartis's move followed the decision by the US Court of Appeals for the Federal Circuit that cleared the way for the firm's SANDOZ unit to start selling ZARXIO, a knockoff version of NEUPOGEN that was approved by the US Food and Drug Administration in March. The drug help to boost the white-blood cell count in chemotherapy patients and others with compromised immune systems.
Unlike generic drugs, which copy classic chemically-made drugs, biosimilars mimic biotechnology drugs made through more complex process involving living cells. The results are a close, but not exact, copy. The US market accounted for more than 70% of Amgen's $1.16 billion in global sales of NEUPOGEN last year.
ZARXIO was the first biosimilar 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.The dispute began when Thousands Oaks, Californica based Amgen filed a lawsuit in federal court in San Francisco last year, accusing Novartis of failing to disclose certain information about its copycat product to Amgen, which the US firm said was acquired under the new criteria for FDA approval of biosimilars. Amgen also called ZARXIO would infringe upon a patent for NEUPOGEN.
