Court Blocks First FDA-Approved Biosimilar, for the Time Being

In March 2015, FDA approved Novartis Sandoz’s biosimilar, Zarxio (filgrastim-sndz), a biologically similar drug to Amgen’s Neupogen (filgrastim). This approval marked the first of its kind within the United States. Zarxio was approved for all five indications for which Amgen’s original drug was approved. However, now Sandoz will need to take the drug off the US market until patent dispute issues are resolved with Amgen. On May 5, 2015, the US Court of Appeals granted Amgen’s request to block the biosimilar from being sold in the US, at least until June 3 when, according to the Wall Street Journal, oral arguments are scheduled. Amgen has appealed the lower-court ruling that allowed Zarxio to enter the US market.

Sandoz agreed to delay sales of Zarxio in the US after it was approved due to the ongoing legal battle with Amgen. Amgen alleged that Sandoz failed to supply Amgen with manufacturing information and a biologics license application (BLA) within 20 days of FDA acceptance, something that it says is US regulatory policy. A US District Judge in San Francisco dismissed Amgen’s request to block the launch of Zarxio on March 19, 2015, stating that neither the failure to provide manufacturing information or the BLA to Amgen, nor Sandoz’s plans to go to market with the drug “constitutes wrongful or unlawful behavior.” Until the end of the injunction, the National Law Review reports that Amgen is required to pay Sandoz bond to cover damages resulting from the biosimilar being taken off the market. 

Source: Wall Street Journal