Sale of biosimilar Zarxio delayed until at least June 3

May 8, 2015

Although the biosimilar Zarxio (filgrastim-sndz,) was approved in March, the manufacturer, Sandoz/Novartis, has been delayed from selling the drug until a patent dispute with Amgen is resolved.

 

Although the biosimilar Zarxio (filgrastim-sndz,) was approved in March, the manufacturer, Sandoz/Novartis, has been delayed from selling the drug until a patent dispute with Amgen is resolved.

Patent litigation could hold up biosimilars

On May 7, the U.S. Court of Appeals for the Federal Circuit in Washington has blocked the sale of Zarxio until oral arguments are heard on June 3, according to a report in The Wall Street Journal.

Amgen claimed that Sandoz did not supply its manufacturing information and biologics license application (BLA) to Amgen within the time frame of 20 days following FDA’s approval of Zarxio. Amgen also alleged that Sandoz’s intent to go to market with its biosimilar equates to “wrongful or unlawful behavior.”

The U.S. District Judge in San Francisco denied Amgen’s request for an injunction to block Zarxio. Amgen appealed the judges’ ruling to the higher court.