FDA Approves First Biosimiar Product in US

FDA today approved Novartis's Zarxio (filgrastim-sndz), the first biosimilar product approved in the US.

Sandoz's Zarxio is biosimilar to Amgen's Neupogen (filgrastim), which was originally licensed in 1991. FDA reports that Zarxio is approved for the same indications as Neupogen, and can be prescribed by a health care professional for:

• patients with cancer receiving myelosuppressive chemotherapy;

• patients with acute myeloid leukemia receiving induction or consolidation chemotherapy;

• patients with cancer undergoing bone marrow transplantation;

• patients undergoing autologous peripheral blood progenitor cell collection and therapy; and

• patients with severe chronic neutropenia.

For this approval, FDA has designated a placeholder nonproprietary name for this product as “filgrastim-sndz.” The Agency said that the "provision of a placeholder nonproprietary name for this product should not be viewed as reflective of the agency’s decision on a comprehensive naming policy for biosimilar and other biological products". FDA has not yet issued draft guidance on how current and future biological products marketed in the United States should be named, but "intends to do so in the near future".