The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States.

Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast.

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.

Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991. 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 more details, go to: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery