2nd Annual Generic Biopharmaceuticals Global Summit

Venue: The Westin Grand

Location: Washington, Distric of Columbia, United States

Event Date/Time: Mar 25, 2004 End Date/Time: Mar 26, 2004
Registration Date: Mar 24, 2004
Early Registration Date: Feb 20, 2004
Report as Spam


At present, biotechnology and pharmaceutical companies are battling biogeneric companies to shape the future of the business. The established biotechnology and drug companies have opposed the concept of biogenerics on the argument that the molecules are too complex to be reproduced safely and efficaciously. Challengers insist that the scientific methods used to characterize these molecules are in place and ready for manufacture. The FDA has been fairly quiet and has not yet ruled on policy. Its European counterparts have supported biogeneric initiatives on that continent. Consequently, the debate rages on.
The biogeneric companies are now trying to penetrate the US and European markets. Will they be permitted to? If they are, how will their entry be governed? The stakeholders – companies with branded biologicals, biogeneric manufacturers, and international regulatory officials – have entered into what will likely be a protracted, expensive, and contentious struggle.
The conference addresses all the relevant topics so you can assess the global market opportunity, or seek protection of your brands, and understand the regulatory pathways that will likely govern the outcome of the high-stakes approval and manufacturing guidelines.