FDA Approves Sandoz's Zarxio, The First Biosimilar Approved in the U.S.

Today, the Food and Drug Administration approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the U.S. Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991. The approval comes two months after an FDA advisory committee recommended Zarxio as biosimilar to Neupogen for all five of the intended indications.  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--in this case Neupogen. 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. 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. FDA issued the following statement in their press release:  “Biosimilars will provide access to important therapies for patients who need them,” said FDA Commissioner Margaret A. Ha...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs