Biosimilars/Biobetters - BioPharm International



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.

Indian Biogenerics: An Evolving Industry

February 1, 2008

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

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.

US Congress Acts on Follow-On Biologics and FDA Funding

July 24, 2007

In late June and early July, the US Congress moved forward on three important bills affecting the biopharmaceutical industry, related to follow-on biologics, the Prescription Drug User Fee Act (PDUFA), and the 2008 FDA budget.

Regulatory Beat: Campaign Accelerates for Follow-on Biologics

May 1, 2007

The information provided by analytical testing is important in determining whether additional clinical trails are necessary to bring a follow-on to market.

Regulatory Beat: Campaign Heats Up for Follow-On Biologics

December 1, 2006

The prospect of any cost savings has been fueling efforts to establish a pathway for follow-on biopharmaceuticals.



Click here