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 Driving Improved Access to Biosimilars
He suggested that biosimilar versions of insulin would be likely to reach the market over the next few years. Almost a year after FDA formally issued its Biosimilars Action Plan (3), with the c…

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 An Analytical Approach to Biosimilar Drug Development
By Feliza Mirasol The long-term safety and efficacy of biosimilars are largely based on clinical studies that have already been conducted on the reference biologic, but these studies may…

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…

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