Biosimilars/Biobetters - BioPharm International



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.

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.

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.

Product Analysis Key to Biosimilar Development

November 1, 2012

Manufacturing and in-depth characterization provide basis for demonstrating product equivalence.

EU Sets Guidelines for Biosimilar mAbs

November 1, 2012

The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on mAbs.

Key Considerations in Biosimilars Development

October 1, 2012

Understanding opportunities and challenges across all major phases of development.

Challenges and Opportunities for Biosimilars Developers

September 1, 2012

Howard Levine of BioProcess Technology Consultants talks about what industry needs to know to enter the biosimilars game in the US.



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