Search results for " biosimilars" in Articles / App Notes
Article
What’s In a Name? For Biosimilars, A Lot
BioPharm: Will naming conventions for biosimilars merely be suggestions, or will they be enforceable by law?
USP: The statutory and regulation provisions described previously relating to naming ap…
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Report: Branded Biopharms Most Exposed to Biosimilar Competition
"But while in Europe more than a dozen products are now commercialized, in the US no company has yet filed for approval of a biosimilar drug since the existence of the FDA's new pathway for biosimilar…
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Analysis of Glycosylation in Biosimilars
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.
The structures of protein drugs such as monoclonal antibodies are mad…
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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
A number of companies have found success in the biosimilars market, having experience in biological drug manufacture, financial muscle, and brand recognition. You will be facing steep competition whil…
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FDA Urged to Preserve Biosimilar Naming Conventions
The Generic Pharmaceutical Association (GPhA) is reporting that 32 organizations, including pharmacies and labor unions, have signed a letter urging FDA to require biologics and biosimilars to have …
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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…