Search results for " biosimilarity"
Poster
Accurate comparability assessment of a biosimilar interferon in process development
This application note describes how to achieve accurate comparability assessments using Biacore™ T200 and
Amersham™ WB system in the development of a biosimilar. This is exemplified in this study…
Article
Using Multiple Techniques in Biosimilar Analysis
Application of multiple techniques at different conditions presents a more complete picture of a dynamic situation.
By Rebecca Strawn
Sergey/stock.adobe.com
Almost all drug product…
Resource
EMA scientific guidance documents on biosimilar medicines
This page lists the scientific guidance documents on biosimilar medicines from EMA.
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Establishment of biosimilarity to the original product is a high standard to meet. Biosimilar manufacturers must show that their product performs comparably in analytical and preclinical assays, and m…
Article
EMA Collaborates with HTA Assessment Networks
High technology assessments are having an impact on biosimilars development in Europe.
Gaining access to Europe’s pharmaceutical markets has become a multi-stage operation. The licensing of a…
Article
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
Legal experts in biopharmaceutical patent law shed some light on trends and recent news.
By Agnes Shanley
…
Article
Biopharma Advances Demand Specialized Expertise
Jun 15, 2015
By BioPharm International Editors
BioPharm International eBooks
Volume 28, Issue 13
Contract service providers share insights on biopharma market developments and the impl…
Article
Biopharma in 2015: A Year for Approvals and Innovations
Insiders agree that 2015 was a banner year for biopharma. Last year’s new drug approvals reached 51, besting every year since 1950. Twenty approvals (39%) went to biological drugs—up from 35% in 201…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology.
By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…