Search results for "biosimilar"
Article
Report: Branded Biopharms Most Exposed to Biosimilar Competition
"We expect development of biosimilar drugs to continue at a rapid pace," says Senior Vice President, Michael Levesque. "But while in Europe more than a dozen products are now commercialized, in the US…
Article
Analysis of Glycosylation in Biosimilars
This adds an additional layer of complexity when proving biosimilarity as, even if the amino acid sequence is the same, the glycosylation pattern may be different, potentially altering the protein’s b…
Poster
Fast Trak Services: a collaborative project to accelerate downstream biosimilar process development
To support this development, mAbxience, a Spanish biotechnology company specialized in research, development, and manufacture of biosimilar drugs, is committed to provide the manufacturing of highqua…
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
Today, however, the competition is really beginning to heat up, with a rising tide of new biosimilar approvals coming from both established companies and new players, including companies in emerging m…
Article
FDA Urged to Preserve Biosimilar Naming Conventions
“These groups understand that the INN approach to biosimilar naming has proven safe and effective in Europe; it has worked in the United States for chemical drugs and currently approved biologics, the…
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.
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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
A cation exchange (CIEX) chromatographic step was developed as part of a collaborative project, where expertise in the field of downstream purification and bioprocessing was combined with specific bio…
Poster
Accurate comparability assessment of a biosimilar interferon in process development
This is exemplified in this study by the use of these systems in the high-throughput process development (HTPD) of a biosimilar molecule, interferon α-2a (IFNα-2a).