Biosimilars/Biobetters - BioPharm International



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.

FDA Guides the Way to Biosimilars in the US

March 1, 2012

Has the long-awaited guidance answered all of the industry's questions?

Biosimilar Developers Face a Reference-Product Dilemma

March 1, 2012

Does global development have to entail multiple comparability studies?

Development and Commercialization of Biosimilars in India

November 1, 2011

The author explains the current status of India, the challenges, and recommendations that may alleviate these challenges.



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