Search results for "biosimilar development"
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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…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
“The so-called 351(k) pathway, which is the biosimilar application, offers both advantages and disadvantages over the current guidelines for biosimilar development in the EU.”
Levine continues, …
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Elucidating Biosimilars Characterization
The global market for biosimilar drugs has been forecasted to be $2.445 billion in 2013 according to a report by the British market-research firm, Visiongain (1). The growth corresponds to a …
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
As the European Union takes a closer look at its biosimilars guidelines, some key issues are proving difficult to resolve.
The European Union is strengthening its pioneering role in the regulati…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Factors that need to be analyzed and controlled for biosimilar development. (Figures courtesy of the authors)
Monoclonal antibodies (mAbs) are at present the fastest growing subclass of biophar…
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Biosimilar Quality Requirements
The draft guidance also emphasizes the need for sponsors to have a thorough understanding of the reference product, which is critical for a successful biosimilar development program. Understanding the…
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FDA Approves First Biosimilar
Mar 06, 2015
By Randi Hernandez
BioPharm International
FDA approved Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. The approval is a groundbreaking decision, as Sandoz is the firs…
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Biosimilars Will Bring Significant Litigation and Patent Challenges
May 04, 2015
By Randi Hernandez
The risks involved with patent suits may become a bit more undesirable, thanks to new legislation aimed at deterring unreasonable patent suits. A senate bill…
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Report: Branded Biopharms Most Exposed to Biosimilar Competition
Many of the largest branded biotech products in the US market today are now in biosimilar development by at least one company, Levesque says, and the pipeline is expanding. Blockbuster biotechs facing…
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Biosimilars Development and Supply: How Complex Can the Process Be?
As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.
Countries around the world face a gro…