Biosimilars/Biobetters - BioPharm International



FDA Releases Draft Guidance on Biosimilarity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Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.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.

Gauging the Outlook of the Biologics Market

September 1, 2013

Mike Jenkins, general manager of Catalent Biologics discusses the evolving landscape of the biologics market and hurdles faced in the development and manufacture of these innovative products.

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.

Elucidating Biosimilars Characterization

September 1, 2013

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

Prescribing Caution for Biosimilars

April 1, 2013

Sound policies are needed to govern the substitution of interchangeable biologics.

Assessing Development Needs for Biobetters and Biosimilars

February 1, 2013

Development requirements and regulatory guidance for biosimilars and biobetters.



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