Biosimilars/Biobetters - BioPharm International

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Biosimilars/Biobetters

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.

Biosimilars' Technology Needs

November 1, 2011

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

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.

Biosimilars or Bust

August 1, 2011

Are biosimilars the next big thing or just the next big bubble?

FDA and Manufacturers Ponder Biosimilars Pathway

July 1, 2011

Follow-on versions of complex biologics require extensive expertise.

Biosimilars Regulation in the US: The Challenges

November 1, 2010

The pathway for biosimilar approval in the US has been set. But are US patients too far behind Europe?

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