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filgrastim
Filgrastim is a granulocyte colony-stimulating factor (G-CSF) analog used to stimulate the proliferation and differentiation of granulocytes; it is a pharmaceutical analog of naturally occurring G-CSF. It is produced by recombinant DNA technology. The gene for human granulocyte colony-stimulating factor is inserted into the genetic material of ''Escherichia coli''. The G-CSF then produced by ''E. coli'' is different from G-CSF naturally made in humans. Amgen originally licensed filgrastim (trade name Neupogen) in 1991.〔
Zarxio, a biosimilar version of filgrastim manufactured by Sandoz, is the first biosimilar approved in the United States.
==Zarxio==
On March 6, 2015, Sandoz’s filgrastim-sndz (trade name Zarxio), obtained the FDA's approval as a biosimilar〔 to Amgen’s filgrastim (trade name Neupogen). This is the first product to be passed under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), as part of President Obama's March 2010 Affordable Care Act.〔 Zarxio was approved as a biosimilar, not as an interchangeable product, the FDA notes. And under the BPCI Act, only a biologic that has been approved as an “interchangeable” may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product. The FDA said its 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.〔
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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