Search results for " zarxio"
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FDA Approves First Biosimilar
To date, there are a total of five 351(k) applications that are publicly disclosed, including the one for Zarxio, said Leah Christl, associate director for therapeutic biologics and biosimilars in the…
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Moving Biosimilars Forward in a Hesitant Market
Still, Gabrielson notes that the US lags roughly 10 years behind Europe in marketing biosimilars, with the first biosimilar, Zarxio (filgrastim-sndz), approved in the US in 2015 (1). “We’re looking at…
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Biopharma in 2015: A Year for Approvals and Innovations
One of the most groundbreaking approvals occurred in March, when the FDA approved the first biosimilar in the US (years after the first such approval in Europe), Sandoz’s Zarxio (filgrastim-sndz). The…
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Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars
New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…
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Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
In contrast, Zarxio has been available in Europe since 2006. There are more than 700 biosimilars approved or in the pipeline globally. Analysts expect the worldwide biosimilars market to reach $25 bil…
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Biosimilars to Drive Modern Manufacturing Approaches
CVS Health recently announced that it would add Sandoz’ Zarxio (filgrastim-sndz) biosimilar to its formulary, with preference over the Janssen reference drug Neupogen, and UnitedHealth took similar ac…
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Framing Biopharma Success in 2016
Peters
The US biopharmaceutical industry turned a new page in 2015 when FDA approved Zarxio (filgrastim-sndz), the first biosimilar approved for use in US markets, in March 2015. Biotechnology sto…
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What’s In a Name? For Biosimilars, A Lot
It has been reported that FDA determined that the United States Pharmacopeial Convention’s (USP’s) monograph for filgrastim does not apply to the first-ever approved biosimilar product, Zarxio (filgra…