Search results for "Biosimilars"

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
Almost a year after FDA formally issued its Biosimilars Action Plan (3), with the challenging goal of balancing patient safety with innovation, the spring and summer of 2019 brought several US congres…

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
…imilar monoclonal antibodies (mAbs) and is drafting another one on the key issue of quality of biosimilars (1, 2). To supplement an eight-year-old basic regulation laying down the general princ…

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…

Next Page