Biosimilars/Biobetters - BioPharm International



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.

Biopharmaceuticals in India: Evolving from Generics to Innovator Drugs

April 1, 2008

The new patent regime is challenging the Indian biopharm industry to transition from generics to novel products.

Book Review: Biopharmaceutical Products in the US and European Markets 6th edition (2 volumes)

April 1, 2008

The book is a useful, comprehensive, and truly an excellent reference source of biopharmaceutical information.

Understanding India's New Patent Laws

April 1, 2008

Did the 2005 Patents Act engender a Western intellectual property rights culture in the country?

Creating Affordable Vaccines for India

March 1, 2008

How an electronics engineer led the first Indian company to carry out indigenous development of a recombinant vaccine.

Biologics Regulation in India

March 1, 2008

India is restructuring its regulation of biopharmaceuticals to help the country's industry compete internationally.

The Role of Analytical Science in the Debate over Biosimilars

February 1, 2008

Both innovator and generics companies are using analytics to support comparability arguments.



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