Search results for "biosimilar development" in Articles / App Notes
Article
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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Moving Biosimilars Forward in a Hesitant Market
The biosimilars landscape is growing as market factors, such as pricing pressure, advanced bioprocessing and analytical technologies, and upcoming patent expirations for innovator biologics dr…
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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 …
Article
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, …
Article
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…