Search results for " filgrastim"
Article
FDA Approves First Biosimilar
Known as Zarzio outside of the US, Sandoz says its biosimilar filgrastim is already available in more than 60 countries worldwide, has generated more than 7.5 million patient-days of exposure, and is …
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …
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EMA Collaborates with HTA Assessment Networks
Biosimilar filgrastim, for the treatment of neutropenia with a granulocyte colony-stimulating factor (G-CSF) analog, had by last year built up market shares ranging from 90–100% in the UK and Sweden a…
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Methods Accelerate Biosimilar Analysis
Of the approved drugs, five are biosimilars of trastuzumab; three are biosimilars each of infliximab and adalimumab; two are biosimilars each of filgrastim, pegfilgrastim, etanercept, and bevacizumab,…
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Biosimilars: Making the Switch Comes with Challenges
In the United Kingdom, the size of the country’s market for filgrastim, a short-acting G-CSF, more than doubled from 2008-2014 (2) after the launch of a biosimilar version. Per Troein, vice-president,…
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Biopharma in 2015: A Year for Approvals and Innovations
As of 2015, the EU approved 19 biosimilars, out of 21 submissions, mostly for three reference biologics such as Somatropin, Epoetin alfa, and Filgrastim.3
In addition, nine of the therapeutic biolo…
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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…
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Biosimilars Will Bring Significant Litigation and Patent Challenges
May 04, 2015
By Randi Hernandez
The risks involved with patent suits may become a bit more undesirable, thanks to new legislation aimed at deterring unreasonable patent suits. A senate bill…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
More complexity equals more development challenges
Compared to the relatively small protein-based drugs for which biosimilars have been approved by EMA, such as epoetins, filgrastims, growth hor…
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Trends in BioPharma Approvals in 2013
While Grastofil (Table I) joins a stable of several biosimilar filgrastims already on the market, the other two products represent first-in-class biosimilar approvals. Ovaleap (Teva Pharmaceuticals) i…