Biosimilars/Biobetters - BioPharm International

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Biosimilars/Biobetters

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?

Biosimilars, Part 3: Interchangeability

September 1, 2010

The third holy grail of biosimilars: interchangeability.

Biosimilars Approvals in the US: The Path Forward

September 1, 2010

An in-depth analysis of the patent provisions of the new legislation.

Rapid Assessment of Molecular Similarity between a Candidate Biosimilar and an Innovator Monoclonal Antibody Using Complementary LC–MS Methods

August 2, 2010

Intact protein LC–MS detected a mass variance of 62 Da and peptide mapping located a difference of two amino acids.

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