The Medical Letter on Drugs and Therapeutics
Zarxio - A Filgrastim Biosimilar
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The FDA has approved filgrastim-sndz (Zarxio – Sandoz), a biosimilar of the recombinant human granulocyte colony-stimulating factor filgrastim (G-CSF; Neupogen), which has been available in the US since 1991. Zarxio is the first biosimilar product to be approved in the US; it has been available in Europe as Zarzio since 2009.

BIOSIMILARS — The FDA defines a biosimilar as a biologic product that is highly similar to an approved biologic product (reference product) with no clinically meaningful differences in safety, purity, or potency; minor differences in clinically inactive components are allowed. An approved biosimilar product must have the same mechanism of action, route of administration, dosage form, and strength as the reference product. Biosimilars can only be approved for the indications for which the reference product is approved; they may be approved for fewer ... more      

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Title: Zarxio - A Filgrastim Biosimilar
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