BIOSIMILARS, ETC.

 Three wonderful women, all dressed up

I have been running onto the term “biosimilar” frequently of late, so I finally got around to looking it up.  Here, more or less, is what I found,

Many (most?) important new anti –cancer drugs are biologics.  These are large organic molecules, usually produced using some biological element – for instance, yeast.  These things tend to be the products of Big Pharma.  It may be that, once discovered, tested, and approved the thing - pill, shot, etc. – can be manufactured for a few bucks a whack.  However, getting to that point may cost the drug company tens of millions of dollars.  Also, as not all such expensively engineered drugs actually work, annually Big Pharma ends up dumping more tens of millions down the rat hole, so to speak.  Thus, to compensate, the FDA allows the drug company to market the drug exclusively for a number of years.  They are granted a patent.  The preposterous prices of some new biologics are the result of the drugs maker’s attempt to cover costs and make a profit.  Maybe not the best system, but of hand I can’t think of one that would work much better.

Then there are these things called “generics”, of which you all have heard.  When the patent runs out on a drug, anybody can step in and market it.  Generics apparently are mostly small-molecule and non-organic.  A common example would be Tylenol and Acetaminophen. 

However, the drugs we are most interested in tend to consist of huge organic molecules, not all parts of which are vital to the function of the drug.  Thus it is possible to produce “biosimilars”, which are much like the original drugs but tweeked a bit to accomplish some useful purpose - most likely, cost reduction.

Neither generics nor biosimilars have to jump through all the FDA hoops that confront their progenitors, although they are still regulated.

So, if all this sounds like a stupid way to run a health system, get in line.  I am all for capitalism and competition on the economic battlefield to lower costs, but do I really want a bunch of Big Pharma behemoths cutting cost and corners on essential drugs?  No way, man!