publication date: Mar. 6, 2015

FDA Approves Zarxio—First Biosimilar Drug


FDA approved Zarxio, making Sandoz’s granulocyte-colony stimulating factor the first biosimilar product to enter the U.S. market.

The agency announced its decision March 6. Biosimilars are approved based on a demonstration that they are similar to already-approved “reference” agents.

The biosimilar 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 allowed.

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

The introduction of biosimilar products will not bring about the same 80 to 90 percent price drops, largely due to limited competition, compared to the introduction of generic versions of small-molecule drugs, according to Rena Conti, an economist at the University of Chicago, whose work focuses on drug pricing (The Cancer Letter, Feb. 6).

Zarxio is approved for the same indications as Neupogen, including: patients with cancer receiving myelosuppressive chemotherapy; patients with cancer undergoing bone marrow transplantation; patients undergoing autologous peripheral blood progenitor cell collection and therapy; acute myeloid leukemia, while receiving induction or consolidation chemotherapy; and severe chronic neutropenia.

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

The approval was made possible by the Biologics Price Competition and Innovation Act of 2009, which was passed as part of the Affordable Care Act and signed into law … Continue reading 41-09 FDA Approves Zarxio, Its First Biosimilar Drug

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