[Ip-health] Two more biogenerics op-eds

[Sarah Rimmington]

The Charlotte Observer
http://www.charlotteobserver.com/viewpoint/story/1037733.html

The UNC Daily Tar Heel
http://www.dailytarheel.com/content/billions-stake-%E2%80%98biologic%E2%80%=
99-medicines


----

Make it easy to create these generic drugs
By Eric Butter
Special to The Charlotte News and Observer
Posted: Thursday, Nov. 05, 2009

In my mind, I still see my grandpa Gerrit as he was 10 years ago. I
remember him as many see those old family movie reels: silent, skipping,
and far too fast. He was my role model, teaching me to read with his
funny character voices in our family room. I remember his "Kermit the
Frog" smile and his sparkling eyes. He was patient. He loved. Now, it is
my turn to show that same patience and love to him. My grandfather has
Alzheimer's disease.

Recently, Wyeth's Bapineuzumab entered phase III trials. Bapineuzumab is
one of the first drugs with the potential to treat the root causes of
Alzheimer's disease - with the potential to help my grandfather enjoy a
few more years with his family. Unfortunately, this "biologic" drug,
like many cutting-edge treatments, will likely come with a steep price
tag. Looking at recent history, a good example is the $48,000 a year
Genentech-Roche charges for Herceptin, a common breast cancer chemotherapy.

Herceptin, a complex protein that prevents cancer cells from
multiplying, is one of many hot new biologics - medicines derived from
living cells. Biologics hold unprecedented potential as vaccines and
therapies for diseases such as diabetes and cancer, but they cost on
average 22 times as much as traditional drugs. Biologics are expected to
account for 50 of the top 100 drugs by 2014.

As these expensive biologics become more common, healthcare costs are
sure to rise. Meanwhile my grandparents, like half of America, live on
an income of less than $50,000. Legislation in its current form provides
no access for one of the most proven ways to lower drug prices: generic
competition.

There is currently no FDA approval process for generic or "biosimilar"
versions of biologics. These generic brands create competition which
pushes down prices 20 to 40 percent and keeps drugs affordable. Generic
drugs have saved Americans more than $700 billion in the past decade
alone. Innovator companies deserve enough protection to make a return on
their investment, but in the meantime patients like my grandfather need
the affordable alternatives that generic competition can provide.

In recent weeks, two congressional committees finally passed proposals
which claim to provide a route for biogeneric FDA approval. Sadly, both
proposals fail to actually provide enhanced access to medicines. In
fact, these proposals could prevent generic competition for biologic
drugs for the foreseeable future.

The proposed framework more than doubles the number of years of
exclusivity offered to brand-name biologics - 12 years - compared with
five years' protection granted conventional drugs. During this monopoly
period, it remains impossible for the generic industry to show the
similarity of their follow-on biologic drugs which is required to gain
approval to enter market.

Worse yet, the proposal contains ambiguous language that provides
loopholes to allow pharmaceutical companies to renew this 12-year
protection over and over by making small alterations to the brand-name
product.

Drug companies claim they need increased protections for biologics
because of higher research and development costs compared with
conventional medicines. However, PhRMA's own 2006 Pharmaceutical
Industry Profile contests that claim, demonstrating that R&D costs for
biologics and conventional drugs are comparable. To justify its demand,
industry points to the fact that biologics take seven months longer in
clinical development than conventional drugs - but they ask for seven
years of extra protection.

The U.S. Federal Trade Commission recommended zero years of exclusivity
for these biologic drugs. Rep. Henry Waxman, D-Calif., and Charles
Schumer, D-N.Y., have championed a compromise of five years - the same
exclusivity awarded to traditional medications. Biogenerics already face
a high threshold for imitation and numerous market barriers, and they
have the potential to save billions of dollars and countless patients'
lives. It is our responsibility to patients, families and friends to
support no more than five years data exclusivity for these essential
medicines.
Butter is a student at UNC Chapel Hill and Duke University, and a member
of the AffordableMedsNow.org campaign. Reach him at egbutter@gmail.com.

Subscribe to The Charlotte Observer & Earn Miles.



----



Billions at stake in =91biologic=92 medicines
1 comments
November 5, 2009
Derek Lundberg
Guest Columnist to the UNC Daily Tar Heel

Expensive medicines can make lifesaving treatments unaffordable. We
allow drug companies to sell at monopoly-level prices to help them
recoup investment, but these high prices come at the expense of our
welfare. Fortunately for traditional drugs, generic competition can
quickly and dramatically reduce prices after the monopoly protection
provided by patents expires.

In contrast to traditional drugs =97 which are small molecules produced
chemically =97 biologics are a different class of medicines made from
living cells. They include vaccines, antibodies, enzymes, stem cells and
blood components, and are currently used in therapies for arthritis and
cancer. They often cost 10- to 20-fold more per year than traditional
drugs, making up about one in eight prescriptions.

There is not yet a mechanism for generic competition in biologics, but
it could reduce prices by 20 percent to 40 percent and save $71 billion
in one decade.

Damaging legislation embedded in the U.S. Senate=92s Committee on Health,
Education, Labor and Pensions and the U.S. House Energy and Commerce
Committee health care bills inordinately delays generic biologics by
creating 12 years of monopoly price protection after FDA approval,
independent of patent protection!

The legislation also leaves open the possibility to =93evergreen=94 monopol=
y
price protections and further postpone a generic market.

In contrast, monopoly prices for traditional drugs are only protected
for 5 years after FDA approval.

Pharmaceutical companies and other supporters of the flawed legislation
contend that biologics are more complicated than traditional drugs and
need more financial incentives to promote innovation.

However, biologics only require on average seven months more time to
develop, and the Pharmaceutical Research and Manufacturers of America=92s
own cited studies show that the cost of developing biologics is similar
to that of traditional drugs .

In June 2009, the Federal Trade Commission recommended zero years extra
monopoly protection for biologics because it concluded consumers will be
reluctant to trust generic biologics, allowing the brand name company to
charge higher prices even after patents expire. Current evidence
supports this.

Fortunately, U.S. Rep. Henry Waxman, D-CA, and U.S. Sen. Sherrod Brown,
D-OH, introduced legislation offering new biologics 5 years of monopoly
protection, similar to what is offered for small molecules.

But Sen. Kay Hagan, D-N.C., is a sponsor of the poor legislation, very
popular with the pharmaceutical industry, that sets 12 or more years of
monopoly protection. This would mean billions of extra dollars from
consumers flowing to large companies, whose advertising budgets are on
average about twice their research and development expenses. And since
early-stage biologics research is government funded, we are already
paying in tax dollars even before the drugs enter the market.

This legislation is not only a domestic problem =97 long periods of high
prices are of serious concern to global health, particularly to
developing countries.

Commonly used biologics currently cost between $20,000 and $200,000 per
patient, per year. Extending monopoly prices for seven years beyond the
protection given to traditional drugs, despite evidence that this
extension is not justified, is an irresponsible gift to pharmaceutical
companies and is an unjustified burden for all of us.



Derek Lundberg is a Ph.D student in Genetics and Molecular Biology.
Contact him at derek.lundberg@gmail.com.

--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: +1 (202) 387-8030
Cell: +1 (202) 422-2687
www.essentialaction.org/access/

Follow me on twitter at http://twitter.com/sarahrimmington