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
Reimagining Affordable Biosimilars
The advent of biosimilars is an opportunity to address affordability. Development costs have been estimated to be reduced to approximately $50 to $300 million and development time to less than eight y…
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
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…