Search results for " biosimilarity"
Article
Ligand-Binding Assays and the Determination of Biosimilarity
While in-vitro and/or in-vivo biological activity assessments provide vital holistic information on biosimilarity, a combination of ligand- and Fc-binding assessments may provide more sensitive and me…
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Elucidating Biosimilars Characterization
Defining biosimilarity
BioPharm: How do you define ‘similar’ when comparing a biosimilar with a reference product, given there will be differences caused by the manufacturing process?
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Article
Methods Accelerate Biosimilar Analysis
…iderations for biosimilars, clarifying regulatory requirements and expectations for demonstration of biosimilarity in support of a marketing application (1).
As the foundation in the developme…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
“First of all, other than saying that FDA will consider interchangeability after one has demonstrated biosimilarity, there really is no discussion as to what the requirements for demonstrating interch…
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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
FDA, Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (Rockville, MD, April 2015).
16. M. Schraeml and M. Biehl, Antib. Methods Protoc. 901,…
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Biosimilar Quality Requirements
…recommendations for the design and evaluation of comparative analytics studies needed to demonstrate biosimilarity between a proposed biosimilar and the reference product. The document also provides …
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FDA Approves First Biosimilar
Biosimilar, but not interchangeable
While the approval is based on strong evidence, says FDA, the agency is careful to state that the biosimilarity designation does not imply interchangeability. A…
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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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Prescribing Caution for Biosimilars
In statehouses around the country, lawmakers are beginning to address the complexities of cutting-edge biotech drugs and the regulatory issues related to the interchangeability of biosimilar medicin…