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!
