Biosimilars/Biobetters - BioPharm International



USP Supports WHO Biologics Naming Proposal

September 25, 2014

USP expresses its support for a consensus-based global approach to the naming of biologics.

FDA Urged to Preserve Biosimilar Naming Conventions

July 2, 2014

Several groups, including pharmacies, call on FDA to preserve accepted International Nonproprietary Name conventions for biosimilars.

Research Firm Predicts Negative Impact of Biosimilars

June 12, 2014

A new report from GlobalData states that biosimilars will overtake the market share after 2019.

FDA Releases Draft Guidance on Biosimilarity

May 14, 2014

Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

Monoclonal Antibodies Key to Unlocking the Biosimilars Market

April 1, 2014

The approval and acceptance of monoclonal antibody biosimilars is necessary if the biosimilars market is to experience real growth.

Advances in UPLC Techniques and Column Chemistry Aid the Confirmation of Biosimilarity

February 1, 2014

Automated sample handling, advanced glycan analysis and specially designed columns are helping biosimilar manufacturers speed up confirmation of the biosimilarity of their products.

EMA Collaborates with HTA Assessment Networks

February 1, 2014

High technology assessments are having an impact on biosimilars development in Europe.

Elucidating Biosimilars Characterization

September 1, 2013

Review the importance of characterization studies during biosimilars development and related analytical methods.

Biosimilars Development and Supply: How Complex Can the Process Be?

September 1, 2013

As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.



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