FDA Approves Sandoz Zarxio as First Biosimilar in the US Market

Sandoz, a Novartis company, is the first company to receive approval of a biosimilar in the US through the new biosimilars pathway.

The US Food and Drug Administration (FDA) approved Sandoz’s Zarxio (filgrastim-sndz) for all indications included in the label of the reference product, Neupogen. Amgen’s Neupogen (filgrastim) was originally approved in 1991. The drug is approved in the US for treatment of patients receiving myelosuppressive chemotherapy; those with acute myeloid leukemia receiving induction or consolidation chemotherapy; patients undergoing bone marrow transplantation; those undergoing autologous peripheral blood progenitor cell collection and therapy; and those with severe chronic neutropenia.

Biological products are generally derived from a living organism, which can come from many sources including humans, animals, mircroorganisms 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 reference product. Additionally, the biosimilar must show that it has no clinically meaningfully 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 approval of Zarxio marks a significant milestone for the United States healthcare system and for patients who might suffer from neutropenia,” said Carol Lynch, Global Head of Biopharmaceuticals & Oncology Injectables at Sandoz. “As the global leader in biosimilars, we are honored to be the first company to successfully work with FDA to navigate the US biosimilar pathway and we look forward to making this high-quality biosimilar available to patients in the US.”

The first-ever approval comes as US policy surrounding biosimilars still evolves. The name filgrastim-sndz was designated by the FDA as a placeholder nonproprietary name for the product. The agency said that the nonproprietary name for the product is not to be viewed as a reflection of the agency’s decision on a comprehensive naming policy for biosimilar and other biological products.

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

The agency’s approval of Zarxio is based on review of 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.

Neupogen generated $1.2 billion in sales last year, and has yet to face generic competition. Although biosimilars are not expected to reduce prices to the extent traditional generic drugs do, analysts expect biosimilars to reduce costs by 20-30 percent.

“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,” said Dr. Louis Weiner, chairman of the department of oncology and director of the Lombardi Comprehensive Cancer Center at Georgetown University. “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.”

Sources: US Food and Drug Administration; Sandoz

Last updated: 3/6/15; 11:30am EST

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