Search results for "biosimilar development"
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The biosimilars market, many analysts believe, is on the cusp of significant growth. This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expect…
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The Bullish Outlook for Biosimilars
More than 150 manufacturers are currently investing in biosimilar development, including many nontraditional players such as digital technology leader Fujifilm and electronics giant Samsung. Since the…
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Reimagining Affordable Biosimilars
In this article, the authors explore the role that these technologies can play in reducing biosimilar development cost and time.
Limitations of clinical studies
Clinical trials have long s…
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Biosimilars: Making the Switch Comes with Challenges
More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.
By Sean Milmo
The use o…
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Driving Improved Access to Biosimilars
In August 2018, in a letter (9) to former Commissioner Gottlieb, representatives from hospitals, insurance companies, and patient groups complained that the lack of final guidance would discourage bio…
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Labeling of Biosimilars
EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.
Feb 01, 2015
By Sean Milmo
BioPharm International
The European Medicines Agency (EMA) has r…
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Ligand-Binding Assays and the Determination of Biosimilarity
During biosimilar development, it is necessary to demonstrate that the physicochemical properties, efficacy, and safety (e.g., immunogenicity) of the biosimilar are similar to those of the …
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Methods Accelerate Biosimilar Analysis
Methods Accelerate Biosimilar Analysis
Effective application of mass-spectrometry tools can optimize biosimilar analysis, reducing development time and cost.
By Mario DiPaola, …
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An Analytical Approach to Biosimilar Drug Development
As such, providing data on the physicochemical comparison between biosimilar and reference product becomes a primary consideration during biosimilar development (1).
Analytical chemists, howe…
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Biosimilars to Drive Modern Manufacturing Approaches
1, 2016, and more are on the way: six companies had announced the submission of at least nine biosimilar applications as of the end of July 2016, and the agency is assisting with more than 60 biosimil…