The EPO crowd in Europe

As the biotech and generics industries escalate their pushing and shoving over biogenerics regulation, market entry strategies for exploiting the expiration of patents on blockbuster biologics are beginning to crystallize.

After the first rush of enthusiasm, would-be biogenerics players have largely abandoned any hope for a purely paper approval process similar to FDA's ANDA, and instead are now focused on obtaining approvals supported by preclinical and Phase III trials demonstrating safety, efficacy and comparability to a marketed product. ...