First Biosimilar Approved

The US Food and Drug Administration (FDA) approved its first biosimilar product filgrastim-sndz (Zarxio/Sandoz), a cancer drug that is similar to Amgen’s filgrastim (Neupogen).

Neupogen was approved in 1991. To be approved as a biosimilar, a product must differ from the original only in clinically inactive components.

The Sandoz product is approved for all the same indications as Neupogen.

Those are for treating 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.

The legislation that enabled the FDA to approve biosimilars was part of the Affordable Care Act and know as the Biologics Price Competition and Innovation Act of 2009.

Still undecided is how such products should be named, and the filgrastim-sndz name is intended as a placeholder, the FDA said in announcing the approval.

The product has potential serious side effects, including spleen rupture, allergic reactions, and acute respiratory distress syndrome.