Anticipating New Regulatory Hurdles
May 01, 2004
The potential of the biotechnology industry to provide blockbuster products is clearly demonstrated by examples like Enbrel (for the treatment of rheumatoid arthritis in adults and of active polyarticular-course juvenile chronic arthritis), Remicade (for the treatment of rheumatoid arthritis and Crohn's disease), and MabThera (for treatment of stage III-IV follicular lymphoma and CD20 positive diffuse large B-cell non-Hodgkin's lymphoma). The EvaluatePharma database1 indicates that at least 265 biotechnology products are currently marketed globally, more than doubling the figure from 1995. It is clear that there are many more blockbuster products to come, with an additional 100 biotechnology products currently in Phase III/preregistration, and a further 1000 reported to be in active development.