Biosimilars/Biobetters - BioPharm International



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.

Five Things Every Biotech Company Must Know About Biosimilars

June 1, 2010

The new US legislation will forever alter the commercial landscape for biologics.

Moving Toward a Biosimilars Pathway: The Lines are Drawn in Congress

July 1, 2009

The introduction of two rival bills has intensified the long-simmering debate on biosimilars regulation in the US.



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