Posts Tagged ‘biogeneric’

Biosimilar drugs to gain greater priority as decade progresses

This is a guest post from Keith Bradbury, Executive Director of Drug Information at Medco Health Solutions, Inc. Biosimilar drugs to gain greater priority as decade progresses The Patient Protection and Affordable Care Act will heighten the degree of competition in the field of biotech drugs, a fast growing area of drug therapy that is […]


Biologic data exclusivity: The arguments for and against it

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 […]


When will the U.S. develop concise generic biologic rules?

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 […]


Generic Biologics: How to Compete

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 […]


An appeal for generic biologic legislation

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 […]