Search results for "biosimilar"

Article The Bullish Outlook for Biosimilars
Kuchenreuther, PhD BioPharm International There are several important reasons for stakeholders to be optimistic about prospects for biosimilars. During the past few years, questions about th…

Article Monoclonal Antibodies Key to Unlocking the Biosimilars Market
This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expected to be launched in the next few years as patents on key drugs, such as infliximab (Remicade…

Article Biosimilars: Making the Switch Comes with Challenges
By Sean Milmo The use of biosimilars continues to increase strongly in Europe, 10 years after the first biosimilar, a somatropin, was approved by the European Union (EU). With approximately 20 new…

Article Labeling of Biosimilars
…tage in the lengthy process of creating a regulatory framework for the development and marketing of biosimilars in Europe. In December 2014, guidelines on quality standards for biosimilars with prote…

Article Biosimilars to Drive Modern Manufacturing Approaches
By Jill Wechsler As more biosimilars gain market approval in the United States, and manufacturers launch additional programs to develop competitive biotech therapies, regulatory authorities and in…

Article EU Sets Guidelines for Biosimilar Monoclonal Antibodies
The London based European Medicines Agency (EMA), which licenses EU pharmaceuticals, has finalized a guideline on biosimilar monoclonal antibodies (mAbs) and is drafting another one on the key issue o…

Article Ligand-Binding Assays and the Determination of Biosimilarity
Therefore, in addition to structural and biochemical analyses of biosimilars for confirmation of the physical and chemical characteristics of the biosimilar, it is necessary to demonstrate that the ph…

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…

Article Key Considerations in Biosimilars Development
Biosimilars are one of the fastest-growing development opportunities in biopharmaceuticals. A Datamonitor study estimates 2009 sales of biosimilar products in the United States and five leading Europe…

Article Current and Future Trends in Biosimilar Development: A Conversation with GE's Gunter Jagschies
Process Development: Do you see that the introduction of the biosimilars class has changed the industry in any way? Yes, in several ways. First, innovation is being fostered and the competition ha…

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