Search results for "biosimilar" in Articles / App Notes
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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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Report: Branded Biopharms Most Exposed to Biosimilar Competition
"We expect development of biosimilar drugs to continue at a rapid pace," says Senior Vice President, Michael Levesque. "But while in Europe more than a dozen products are now commercialized, in the US…
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Analysis of Glycosylation in Biosimilars
This adds an additional layer of complexity when proving biosimilarity as, even if the amino acid sequence is the same, the glycosylation pattern may be different, potentially altering the protein’s b…
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Biosimilars Development and Supply: How Complex Can the Process Be?
The goals behind the safe and regulated introduction of biosimilars into the market include increasing access to much-needed biologic medicines and reducing costs (2).
A recent report (3) from …
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The Good and Bad of Biosimilars
Today, however, the competition is really beginning to heat up, with a rising tide of new biosimilar approvals coming from both established companies and new players, including companies in emerging m…
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FDA Urged to Preserve Biosimilar Naming Conventions
“These groups understand that the INN approach to biosimilar naming has proven safe and effective in Europe; it has worked in the United States for chemical drugs and currently approved biologics, the…
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Do Modeling and Simulation Tools Really Benefit the Biosimilar Industry?
The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.
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Using Multiple Techniques in Biosimilar Analysis
Whether they are called ‘sameness’ for generic drugs, ‘comparability’ for biologics, or ‘analytical similarity’ for biosimilars, these tests are crucial for any regulatory submission, which is vital t…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Now that biosimilars are here to stay, manufacturers are developing processes for cost efficiency and reliability using newer technology to compete with innovator products based on processes 10-15 yea…
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EMA Collaborates with HTA Assessment Networks
The Impact of HTAs on Biosimilars
As a result of cuts in healthcare costs due to post-recession austerity programs, favorable HTAs are becoming crucial to the successful market launch of pharmace…