Enbrel. Make it generic baby!

I recalled that Enbrel, being one of the first biologics developed, must be coming up to the end of its’ patent soon.  Those of you who have read about me will know that the first biologic I went on was Enbrel, and I had excellent results.  Biologic drugs are the closest thing to a cure for many arthritis sufferers, however the fear of not being able to afford the medication is always at hand.  It is difficult to explain to someone who has never experienced chronic relentless pain, the profound difference something like Enbrel can  make on quality of life.  Let’s just say that through my experience with biologics that I perhaps can understand to a better degree the behavior that drives some drug addicts.  How would I be if my job suddenly did not cover the cost of my Remicade?  Would I resort to theft, or other illegal means, in order to be able to finance my treatment?  I know what it is like to have uncontrolled arthritis – and the pain is truly horrific.  My fingers are crossed that I never will be put in that position!

The fact is that there are millions of people out there who would benefit from a biologic, but who cannot afford the treatment.  Enbrel (and the other biologics) are expensive!  The reason that they are expensive is because all of them (being a new class of drug) are still under patent, and so no (cheap) generics have been developed and put on the market.  So I did a quick search today and found that yes, the patent for Enbrel is due to expire next year (2012).  You can read about it here (scroll to the end of the article for the pertinent information).  Will the expiry of the Enbrel patent herald the arrival of cheaper biologics?  I really hope so.  However the literature gives a warning that development of a generic biologic will not be easy.

The article I have referenced states:

Amgen’s arthritis and psoriasis treatment Enbrel is a large-molecule biologic. As such, it will be much harder to duplicate. Even with the FDA trying to put in place procedures to ease the entry of generic biologics, or biosimilars, into the market, the process is just beginning.”

However even though it seems like it is very difficult to make a generic biologic, the drug companies know that whoever succeeds will make a huge profit, so it appears that they are working hard on this (which is great for us!):

“Both [the generic and brand-name pharmaceutical] industries are increasing their emphasis on biologic drugs, which are harder to replicate, but were recently given a 12 year limit on patent protection via the Patient Protection and Affordable Care Act,” explained Snyder. “The brand name industry sees a lot of potential revenue here, and the generic industry is already increasing their R&D investment to find ways to create biosimilars.”

It would be wonderful if come 2012 some companies in the pharmaceutical industry were successful in creating some generic biologics.

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