FDA Approves First Biosimilar in US

Today the FDA approved the first biosimilar product in the United States. Zarxio (filgrastim-sndz), from Sandoz, Inc, is biosimilar to Amgen Inc’s Neupogen (filgrastim), which was first licensed in 1991.

“Biosimilars will provide access to important therapies for patients who need them,” FDA Commissioner Margaret A. Hamburg, MD, said in a statement. “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.”

Zarxio can be prescribed 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.

Zarxio is contraindicated for in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors, such as filgrastim or pegfilgrastim. The most common side effects of Zarxio are aching in the bones or muscles and redness, swelling, or itching at the injection site. Serious side effects include spleen rupture, serious allergic reactions, and acute respiratory distress.

The approval was based on evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates Zarxio is biosimilar to Neupogen.

"Filgrastim has proven clinical value in treating patients at increased risk of neutropenia, but it is underused in the US for a variety of reasons, including price" Louis Weiner, MD, chairman of the department of oncology and director of the Lombardi Comprehensive Cancer Center at Georgetown University, said. "Biosimilars have the potential to increase access and the approval of Zarxio may reduce costs to the healthcare system. The comprehensive data set supports its use in clinical practice."

The FDA Oncologic Drugs Advisory Committee recommended approval for Zarxio back in January. Sandoz biosimilars have been sold in more than 60 countries.

According to the FDA’s Leah Christl, PhD, associate director for therapeutic biologics, the introduction of biosimilars to the US marketplace will likely create greater competition, increasing treatment options for patients and leading to less expensive alternatives to comparable drugs.

“The FDA approval of Zarxio marks a significant milestone for the United States healthcare system and for patients who might suffer from neutropenia,” Carol Lynch, global head of biopharmaceuticals and oncology injectables at Sandoz, said in a statement.