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News From the Food and Drug Administration
April 21, 2015

First Biosimilar Product Approved

JAMA. 2015;313(15):1507. doi:10.1001/jama.2015.3309

The first biosimilar product in the United States recently gained approval from the Food and Drug Administration (FDA).

Sandoz’s Zarxio was approved for the same indications as Amgen’s Neupogen, which boosts the production of white blood cells in patients with cancer who are receiving myelosuppressive therapy or undergoing bone marrow transplantation.

A biosimilar product must be highly similar to a biologic product already on the market. Only minor differences in clinically inactive components are allowed.

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