Posts Tagged ‘healthcare’

Introduction

Currently there is a huge debate regarding whether the United States should have universal healthcare.  This debate seems to have energized both sides of the argument.  However, there is a sub-argument that is often overlooked by the usual participants: should there be a short or long exclusivity period for biosimilars (also called follow-on biologics).

After reading many articles and listening to the pundits of cable news regarding healthcare reform, I noticed that the arguments tended to always center on the pharmaceutical industry.  This is because the pharmaceutical and healthcare industries share a symbiotic relationship such that as one goes, so will the other.  The future of the pharmaceutical industry lies with biotechnology.

Biotechnology related drugs account for around ten to fifteen percent of the current pharmaceutical market.  Moreover, biotechnology is outperforming the pharmaceutical industry as a whole in terms of growth, because much of the biotechnology sector revolves around biosimilars.  Biosimilar is the term coined for protein drugs that are similar, but not identical to, an existing pharmaceutical product.  Biosimilars are different because a single protein can exist in many forms because of a protein’s ability to change conformations.  A single protein can react one way when it is in one conformation, and totally differently when the conformation is changed.  For example, as pharmaceutical companies do not disclose the techniques that they use to create the biosimilars, it is almost impossible for a generic drug producer to use a process identical to the process responsible for creating the original drug.  Since the drugs created by biosimilars are essentially different from the original drug, they are able to obtain patents on their own merits.  In addition to patent protection, companies who create biosimilars are given an additional exclusivity period on their data.

Today there are two schools of thought regarding the data exclusivity period.  There is what I will call the “Howard Dean School” where it is argued that the exclusivity period should be between twelve and fourteen years and the “Obama School” which advocates that the exclusivity period should be seven years.  I will try to sum up the two schools and explain why I believe that Howard Dean is right and the President is wrong. Read the rest of this entry »