The Patent Docs blog is promoting a conference on Follow on Biologics in NYC from June 21-22. The conference will present sessions covering topics such as:
- impact of the 12 yr exclusivity period
- methods for demonstrating or disproving similarity
- determine safety data and technical support needed
- maximize biologic patent life
- alternative methods for approval
- overview history of US biosimilar legislation
- current FDA position on biosimilars
- lessons learned from biosimilars in international markets
This is obviously a hot area with passage of the Healthcare Reform bill. It will likely only get hotter as biosimilars take on even greater importance with the Big Pharma pipelines drying up and their moving into the biosimilar space. Biosimilars will of course have great impact on the growth of the World pharmaceutical market, especially in pharmerging markets. As such, I thought it was worth passing on the information regarding this conference.
Posted by Bruce Lehr May 1st 2010.
Good post on this topic by the FDA Matters blog via Seeking Alpha.
http://seekingalpha.com/article/202565-will-biosimilars-alter-biotech-landscape
Posted by: Bruce Lehr | 05/03/2010 at 09:11 PM