Biosimilars/Biobetters - BioPharm International



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.

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.

Indian Biogenerics: An Evolving Industry

February 1, 2008

Indian biogenerics could form a major piece of the global biotherapeutics market in the future.

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.

What Follow-on Biologics Mean for the Future of the Biotechnology Industry

November 1, 2007

The industry needs a clear regulatory pathway for the approval of biosimilars.

Protein Therapeutics and the Regulation of Quality: A Brief History

October 1, 2007

Regulatory agencies have evolved along with the biotechnology industry to define quality standards.

Biotech Manufacturers Face Competition from "Similar" Follow-Ons

August 1, 2007

The main testing and regulatory provisions of the FOB legislation reflect multiple trade-offs between the demands of innovators and generics firms.



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