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- Title
First Biosimilar Drug Approved for Sale in the United States.
- Authors
Hede, Karyn
- Abstract
The article discusses the implications of the decision by the U.S. Food and Drug Administration (FDA) to approve Sandoz's ilgrastim-sndz, a biosimilar of Amgen's filgrastim, which counteracts chronic neutropenia by stimulating the production of immune system-boosting white blood cells. It cites clinical trials of trastuzumab biosimilars being conducted by various companies. It also describes the impact of oncologists' willingness to prescribe biosimilars on the price of biologics.
- Subjects
DRUG approval; NEUTROPENIA; UNITED States. Food &; Drug Administration; GRANULOCYTE-colony stimulating factor; BIOLOGICALS; DRUG prescribing; THERAPEUTICS; PRICES
- Publication
JNCI: Journal of the National Cancer Institute, 2015, Vol 107, Issue 7, p1
- ISSN
0027-8874
- Publication type
Article
- DOI
10.1093/jnci/djv191