Follow on Biologics

Earlier today, I moderated an all day meeting at the National Press Club in Washington DC on a key topic---the policy questions surrounding follow on biologics or FOBs. Biologic drugs, the so called big molecules, include some of the greatest scientific breakthroughs of the last decade. These drugs are giving hope to thousands of patients. They are expensive to create and they do cost more than small molecules or non biologic products. There is an industry out there interested in trying to create a type of "generic product", a FOB. The challenge here is that a FOB is not biologically equivalent to an original innovative product. In addition, the FDA does not have a pathway that makes sense to approve these FOBs. Our program today, with experts from around the nation, demonstrated the need for an urgent policy solution to these issues. We will create a special edition of our journal, Biotechnology Healthcare, that will highlight these findings. For now, pay attention to what happens on Capitol Hill as we struggle with the FOB question. Much more news to follow. Does your institution support the FOBs?? DAVID NASH