Search results for "Biosimilars"
Article
Report: Branded Biopharms Most Exposed to Biosimilar Competition
"But while in Europe more than a dozen products are now commercialized, in the US no company has yet filed for approval of a biosimilar drug since the existence of the FDA's new pathway for biosimilar…
Article
Analysis of Glycosylation in Biosimilars
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.
The structures of protein drugs such as monoclonal antibodies are mad…
Poster
Fast Trak Services: a collaborative project to accelerate downstream biosimilar process development
Biosimilars represent an innovative solution that can benefit both patients and healthcare systems by reducing the burden of rising treatment costs. To improve the availability, price and access of…
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
The goals behind the safe and regulated introduction of biosimilars into the market include increasing access to much-needed biologic medicines and reducing costs (2).
A recent report (3) from …
Article
The Good and Bad of Biosimilars
A number of companies have found success in the biosimilars market, having experience in biological drug manufacture, financial muscle, and brand recognition. You will be facing steep competition whil…
Article
FDA Urged to Preserve Biosimilar Naming Conventions
biosimilars," said Ralph G. Neas, president and CEO of GPhA, in a press release. “The organizations who know the most about healthcare delivery agree: departing from the currently accepted INN system …
Article
Do Modeling and Simulation Tools Really Benefit the Biosimilar Industry?
The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.
READ THE FULL ARTICLE >>…
Poster
To Speed Up the Process Optimization of the Described Biosimilar Product
…;resin and running conditions were selected based on experience and adapted to meet requirements of biosimilars.
Poster
Rapid Process Development of a CIEX Step for a Biosimilar
When establishing purification processes for a biosimilar molecule it is important to develop steps that are scalable, selective, and cost-effective.
A cation exchange (CIEX) chromatographic ste…
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…