Search results for " biosimilars"
Article
Elucidating Biosimilars Characterization
Although narrowly focused on only a small number of therapy areas at present, the biosimilars market is set to expand over the next decade and beyond as a result of two major factors: the impending pa…
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Methods Accelerate Biosimilar Analysis
In May 2019, FDA published a draft guidance on the analytical assessment and other quality-related considerations for biosimilars, clarifying regulatory requirements and expectations for demonstration…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
Howard Levine, President and Principal Consultant of BioProcess Technology Consultants, about what these guidelines mean for developers of biosimilars. Dr. Levine is based in Woburn, Massachusetts, in…
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
The European Union is strengthening its pioneering role in the regulation of biosimilars by further developing the basic rules for determining the levels of compatibility for this group of drugs. Ther…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
As such, developers of biosimilars must put together a toolbox of state-of-the-art technologies. Companies such as Sandoz and Celltrion, which have both received FDA approvals for biosimilars, have ha…
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Biosimilar Quality Requirements
By Feliza Mirasol
Recent guidelines released by FDA emphasize the agency’s efforts to ease the path toward regulatory approval for biosimilars and marks significant action taken by the agency to h…
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FDA Approves First Biosimilar
To date, there are a total of five 351(k) applications that are publicly disclosed, including the one for Zarxio, said Leah Christl, associate director for therapeutic biologics and biosimilars in the…
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Biosimilars Will Bring Significant Litigation and Patent Challenges
Many intellectual property lawyers believe the procedure for patent disputes for biosimilars in the pipeline will likely be complicated. Even though one of the key objectives of the Biologics Price Co…
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Prescribing Caution for Biosimilars
[Will legislative efforts impact the biosimilars market? Join the conversation on the front page poll.]
Two biologics made using different cell lines and manufacturing processes will rarely, if …
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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…