Biotech Values

[DewDiligence]

Teva plans 2009 BLA submission of US Neupogen ‘biosimilar’:

http://www.reuters.com/article/marketsNews/idINN1846941120090219

This is same approach being followed by MRK in its new push into biologics: rather than waiting for Congress to pass FoB legislation that would enable FDA applications to be based on an abbreviated clinical program, these companies are treating their biosimilars as new branded drugs and are running full-fledged clinical programs to show safety and efficacy.