Filgrastim-sndz debuts as the first biosimilar approved in United States

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Fri, 01/04/2019 - 11:11

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In March this year, filgrastim-sndz became the first biosimilar to receive approval from the US Food and Drug Administration for use in the United States. Biosimilars are biological products that show comparable quality, efficacy, and safety to a reference drug that is already approved. In this case, filgrastim-sndz, by Sandoz, a Novartis company, is a biosimilar of Amgen’s filgrastim, the reference drug or originator, which is already licensed in the United States for 5 indications, including for cancer patients undergoing treatments that deplete white blood cells, as well as those preparing for autologous peripheral blood stem-cell transplant, or those with severe, chronic neutropenia.¹

Click on the PDF icon at the top of this introduction to read the full article.

Article PDF

JCSO_dec_420_Abraham.pdf

Issue

The Journal of Community and Supportive Oncology - 13(12)

Publications

The Journal of Community and Supportive Oncology

MDedge Hematology and Oncology

Topics

Patient & Survivor Care

Page Number

420-422

Legacy Keywords

Biosimilars, filgrastim, figrastim-sndz, granulocyte-colony stimulating factor, G-CSF

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Community Translations

Author(s)

Edited Jame Abraham

Author(s)

Edited Jame Abraham

Article PDF

JCSO_dec_420_Abraham.pdf

Article PDF

JCSO_dec_420_Abraham.pdf

In March this year, filgrastim-sndz became the first biosimilar to receive approval from the US Food and Drug Administration for use in the United States. Biosimilars are biological products that show comparable quality, efficacy, and safety to a reference drug that is already approved. In this case, filgrastim-sndz, by Sandoz, a Novartis company, is a biosimilar of Amgen’s filgrastim, the reference drug or originator, which is already licensed in the United States for 5 indications, including for cancer patients undergoing treatments that deplete white blood cells, as well as those preparing for autologous peripheral blood stem-cell transplant, or those with severe, chronic neutropenia.¹

Click on the PDF icon at the top of this introduction to read the full article.

In March this year, filgrastim-sndz became the first biosimilar to receive approval from the US Food and Drug Administration for use in the United States. Biosimilars are biological products that show comparable quality, efficacy, and safety to a reference drug that is already approved. In this case, filgrastim-sndz, by Sandoz, a Novartis company, is a biosimilar of Amgen’s filgrastim, the reference drug or originator, which is already licensed in the United States for 5 indications, including for cancer patients undergoing treatments that deplete white blood cells, as well as those preparing for autologous peripheral blood stem-cell transplant, or those with severe, chronic neutropenia.¹

Click on the PDF icon at the top of this introduction to read the full article.

Issue

The Journal of Community and Supportive Oncology - 13(12)

Issue

The Journal of Community and Supportive Oncology - 13(12)

Page Number

420-422

Page Number

420-422

Publications

The Journal of Community and Supportive Oncology

MDedge Hematology and Oncology