Biosimilars/Biobetters - BioPharm International

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Biosimilars/Biobetters

Product Analysis Key to Biosimilar Development

November 1, 2012

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

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?

Biosimilars' Technology Needs

November 1, 2011

Biosimilar manufacturers need better expression systems and analytical tools to compete.

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.

Navigating the Biosimilars Market

September 2, 2011

The market landscape for biosimilars is in flux, with limited penetration now, but with the potential for growth for those who can navigate the market. Plus: A SWOT analysis of biosimilars by Anjan Selz.

Advocating for Biosimilar Approval Standards Under BPCI

September 1, 2011

FDA weighs multiple views regarding the Biologics Price Competition and Innovation Act.

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