A US appeals court has blocked Novartis from selling the first biosimilar to be approved in the United States. When Sandoz, a Novartis company, acquired FDA approval for Zarxio (filgrastim-sndz) a ...

Sandoz is the first company to receive approval of a biosimilar in the US through the new FDA biosimilars pathway established under BPCIA Approval paves way for greater access to high-quality ...

On Friday, the Food and Drug Administration approved the first biosimilar, marking an initial big step foward in changing the climate of the drug market in the United States. Time to save some money.

The U.S. Food and Drug Administration has approved Zarxio, the first-ever biosimilar product for use in the United States. Above, an Indian supervisor inspects pre-filled syringes of the biosimilar ...

A year ago, providers, plans and pharmacy benefit managers thought they were on the brink of a new era of competitive drug prices. The federal approval of the first biosimilar for sale in the U.S. was ...

A judge for the US Court of Appeals for the Federal Circuit declined an Amgen motion for a temporary injunction that would have prevented the launch of the first biosimilar in the US—Novartis’s Zarxio ...

The Food and Drug Administration has approved its first biosimilar, Zarxio (filgrastim-sndz), for all five of its counterpart Neupogen's authorized indications. The Food and Drug Administration has ...

zarxio The FDA has approved a supplemental Biologics License Application (sBLA) for Zarxio (filgrastim-sndz; Sandoz) to update the Warnings and Precautions section of the drug label. The Food and Drug ...

The first biosimilar medication approved for use in the U.S. made its way to the market on Thursday, ushering in a new era of competition between such drugs and the original high-cost biologic ...

After many legal proceedings surrounding the first FDA-approved biosimilar, Zarxio officially launched commercially on Sept. 3, 2015. Sandoz announced on Sept. 3, 2015 that despite the barriers ...