FDA approves first biosimilar product

The FDA today announced the approval of filgrastim-sndz, the first biosimilar product approved in the United States.

“Biosimilars will provide access to important therapies for patients who need them,” Margaret A. Hamburg, MD, FDA commissioner, said in a press release. “Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”

Filgrastim-sndz (Zarxio, Sandoz) is biosimilar to filgrastim (Neupogen, Amgen), which was licensed in 1991.

A biosimilar product is a biological product that is approved based on evidence that it is highly similar to an already-approved biological product. The biosimilar must demonstrate 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.

The FDA based its decision on structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates filgrastim-sndz is biosimilar to filgrastim.

Filgrastim-sndz is approved for the following indications:

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 most common adverse effects associated with filgrastim-sndz include aching in the bones or muscles and redness, swelling or itching at the injection site.

Serious adverse effects of using filgrastim-sndz may include spleen rupture; serious allergic reactions that may cause rash, shortness of breath, wheezing and/or swelling around the mouth and eyes; fast pulse and sweating; and acute respiratory distress syndrome.

In January, the FDA’s Oncologic Drugs Advisory Committee unanimously recommended the approval of biosimilar filgrastim.