Biotech Blog

With the issue of data exclusivity for novel biologics re-emerging in the news, I’d like to present two arguments that will be published in the upcoming issue of the Journal of Commercial Biotechnology:
Why data exclusivity is the new patent protection
Peter J Pitts, Center for medicine in the public interest
Follow-on biologic drug competition – No [...]

A lot of people have been asking my opinion on when a concise generic biologic regulatory pathway will emerge in the United States, and I give them all the same answer: Later.
In my opinion complex regulatory schemes are not areas in which the United States can effectively lead. Why not? Because the size of the [...]

Guest content from John Avellanet, managing director and principal of Cerulean Associates:

Follow-on biologics are a foregone conclusion in the US. Too much money is at stake. The more difficult discussion starts with how to prepare your company to compete.
Science Succumbs to Dollars
The financial pull on reimbursement organizations and the constituent push on [...]

The following appeal for generic biologic legislation was sent in from Insmed via youtube.
I’ve posted previously on the challenges of developing a framework for generic biologic approvals and questioned how much we can really expect to save. In the editorial for the upcoming issue of the Journal of Commercial Biotechnology, I argue that the United [...]