Zarxio Wins First Biosimilar Approval, but isn't Considered Interchangeable

The U.S. FDA has approved Zarxio, the first drug in the U.S. that was developed through the recently established biosimilar regulatory pathway, clearing the way for market competition.

Novartis Sandoz' Zarxio, a similar version of Amgen's reference biologic, Neupogen (filgrastam), was approved last week for all of the same indications as Neupogen. The approval will open the door for other drugmakers to pursue biosimilar versions of Neupogen.

However, pharmacists will not be able to automatically substitute Zarxio for Neupogen, which means physicians will have to specifically prescribe Zarxio for patients. Additionally, while Zarxio will be priced competitively relative to Neupogen, the cost savings between the two drugs in the EU is only a 26% discount -- much less than the discount seen in the traditional, small molecule generic drug market.

According to Seeking Alpha, Amgen and Sandoz will be in federal court on Friday to argue over an injunction sought by Amgen, seeking to block the launch because Sandoz has declined to participate in patent disclosure procedures.

Read the business wire press release