FOB:
Follow-on Biologics or Full of Baloney?

By

Leonard
Zwelling

       The two links below do a good job outlining
the problem.

       It will come as no shock to the
oncologists out there that biologic agents like proteins and antibodies
extracted from living systems like cells in culture are valuable agents in the
treatment of malignancy. Herceptin, Erbitux, and Rituximab are only three
examples of biologic drugs that have come into common use in the therapy of
cancer.

       What many health care professionals are
unaware of is the battle going on over generic versions of these same drugs.
These generic proteins are known as follow-on biologics or biosimilars (n.b.,
similar ain’t identical). What may be even more surprising is that the entirety
of Title VII of the ACA is called the Biologics Price Competition and
Innovation Act (BPCIA) and is the basis of what the supporters of the bill hope
will be a growth industry in generic versions of some of your favorite drugs.

       The Health Affairs policy brief below tells
the tale of confusion wrought by this legislation. The unintended consequences
are significant and I was fortunate enough to be present when the negotiations
took place that gained some limited protection for the innovative companies
that first developed these unique drugs. It was one of the staff members in the
office in which I worked who stood down the Kennedy people’s wanting to shorten
the protection for the innovative first molecules like Herceptin. This
shortened period could have eliminated any impetus to develop new drugs, a
costly process requiring extensive clinical trials prior to gaining FDA
approval.

This regulation of biologics is quite
different than the system used to get generic versions of small molecules
approved and out to the market under the Hatch-Waxman Act of 1984. Thus, the needed legislation as Hatch-Waxman did not cover FOBs.

       What was so curious to me was the tacit
assumption on the part of the Democrats formulating the ACA that anyone could
synthesize a molecule like Herceptin and derive a working drug. For months I
tried to explain that as an oncologist (or a husband), I would never administer
generic Herceptin that had not been proven to be at least as good as the real
stuff in a clinical trial.

I tried to explain things like
post-translational modification of proteins and folding of these proteins to
Congressional staffers (now, who’s the idiot?). I knew I was in trouble explaining
this when the head health staffer in the Health, Education, Labor and Pensions office
in which I served asked me to explain the difference between a polypeptide, a
protein and an antibody. (I said big, bigger, biggest and sent him pictures). Staffers on the Hill are not the ex-winners of the science fair.

       This is all illustrative of the doctors’
dilemma when it comes to health care legislation and in fact the governance of
medicine as a whole. We have spent the last 50 years passively watching as
legislators, administrators, lawyers and accountants have determined how we would
practice, how we would be paid (if at all) and how the science underpinning
that practice would be overseen. To be blunt, we should be saying to Congress as
my father-in-law said to me many times: “What do you know?”

       Fortunately, when it comes to FOBs, the
jury is still out. The FDA has not completely outlined the pathway by which
generic versions of biologics will make it to market and whether or not
pharmacists will be free to substitute generic biologics for the real thing
when an oncologist writes an order.

For goodness sakes, speak up! You all know
more than I do about the proper use of these drugs and what an appropriate test
would be that would allow you to comfortably and confidently substitute a
generic for the real deal and feel that the patient, like your wife
or mother, would be getting the best chance for a good result.

       The leaders of the Division of Cancer
Medicine ought to take a formidable role in influencing the details of the FDA pathway
that a manufacturer of an FOB needs to follow to get to the clinic and not use
their buddies in pharma to do it for them. Get up on the Hill and let your
member representatives know what you think.

Don’t fall for the baloney. Either you stand
for something or you’ll fall for anything. Be heard!  

http://about.bloomberglaw.com/practitioner-contributions/pathway-for-follow-on-biologics/

http://healthaffairs.org/healthpolicybriefs/brief_pdfs/healthpolicybrief_100.pdf

Leonard Zwelling