Search results for " sandoz"
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FDA Approves First Biosimilar
The approval is a groundbreaking decision, as Sandoz is the first pharmaceutical company to have a biosimilar product approved in the United States. Known as Zarzio outside of the US, Sandoz says its …
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Biosimilars to Drive Modern Manufacturing Approaches
Payers and consumers are looking for reliability in production systems to meet the demands of the larger US market, added Sandoz US President Peter Goldschmidt. He and other leaders in the biosimilars…
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Biosimilars Will Bring Significant Litigation and Patent Challenges
In that instance between Sandoz and Amgen, Sandoz did not disclose its manufacturing processes and FDA application to Amgen, the patent holder for Neupogen (filgrastim). A California judge ruled, howe…
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Driving Improved Access to Biosimilars
Since 2015, when FDA approved its first biosimilar, Sandoz’s filgrastim-sndz (Zarxio), 19 biosimilars have been approved in the US. Thomas Linneman, head of regulation CMC customer solutions at Solvia…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Companies such as Sandoz and Celltrion, which have both received FDA approvals for biosimilars, have had success in using real-time, label-free biophysical analytics as a platform approach for product…
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Biosimilars: Making the Switch Comes with Challenges
Market trends
Biosimilar versions of granulocyte-colony stimulating factor (G-SCF) have now gained a market share of more than 50%, Carol Lynch, global head of Sandoz Biopharmaceuticals said durin…
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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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Biopharma Advances Demand Specialized Expertise
Recent FDA approval of the Sandoz biosimilar, Zarixo, may be the seed for similar changes in the US providing a potential new line of business for established pharmaceutical companies. Contract servic…
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The Bullish Outlook for Biosimilars
A few months ago, FDA accepted Sandoz’s and Celltrion’s biosimilar applications (7). The opening of the US market will mark a turning point. The cost of drugs has become a focal point of popular and i…
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Pharma Investments Reflect Key Industry Trends
…cals business, a strong position in eye care through its Alcon unit, leadership in generics with its Sandoz business, and is well-positioned for innovation with Novartis Institutes for BioMedical Res…