against Richard Oropeza’s brain tumor, is now
also widely used to treat lung, breast, colon, and
rectal cancers. Other monoclonal antibody biologics are designed to attack certain proteins (or
protein receptors) on the surface of cancer cells
and stop their growth. Examples of such protein
inhibitors include Rituxan, which is used to treat
lymphomas, and Herceptin.
Other biologics alter the function of the immune system by either suppressing or enhancing certain responses. In autoimmune diseases
such as rheumatoid arthritis and psoriasis, for
example, the immune system overproduces a
protein that triggers a buildup of white blood
cells, which leads to excessive inflammation and
joint damage. Enbrel, Humira, Remicade, and
other biologics in this class target that protein,
called the tumor necrosis factor, and block its
action. Tysabri, a biologic used to treat multiple
sclerosis and Crohn’s disease, blocks the passage of inflammatory cells into the brain and the
spinal cord—and, in the case of Crohn’s disease,
into the intestines.
“These biologic agents provide a degree of
selectivity not achievable with conventional
chemotherapy drugs,” explains oncologist Oliver
Press, M.D., Ph.D., of the Fred Hutchinson Cancer Research Center in Seattle. “Many of [the bio-logics] can produce dramatic antitumor effects
without the toxicity that historically has been
associated with chemotherapy and radiation.”
OPPOSITE: ANDY REYNOLDS; THIS PAGE: THOR SWIFT/THE NEW YORK TIMES/REDUX
Biologic treatments date back to 1982, when
recombinant insulin was first approved in the
United States for the treatment of diabetes. (A
hormone originally derived from the pancreas of
animals, insulin is today made synthetically from
genetically engineered human bacteria.) Since
then, more than 300 biologic drugs, most of them
developed in the past five years, have flooded the
pharmaceutical market. Today they constitute
roughly 25 percent of all new drugs approved by
the FDA; by 2014, industry insiders predict, more
than half of the top 100 drugs will be biologics.
The growth is fueled in part by their effectiveness. Two 2005 studies sponsored by the
National Cancer Institute showed that adding
Herceptin to standard chemotherapy reduced
the risk of recurrence by 52 percent. A 2004
study published in the New England Journal of
Medicine found that adding Avastin to chemotherapy extended life by 4. 7 months for those with
colorectal cancers. And studies have established
that the addition of Rituxan to the standard chemotherapy regimen for certain types of chronic
INNOVATION
AT WORK
A researcher
who works for
Genentech,
which makes
several
biologic
medicines,
extracts DNA
from tissue
samples.
The fight to
control costs
heats up
BY SHEREE CRU TE
WHAT PRICE A MIRACLE?
WHY DO BIOLOGICS
COST SO MUCH?
“Biologics are proteins
taken from living
things,” says Thomas
Hazlet, Pharm.D., a
professor at the University of Washington.
That means they’re
naturally more expensive to develop and
manufacture than
chemical drugs (see
“How They’re Made,”
page 58). But there is
also no competition
for biologics in the
pharmaceutical marketplace, in part because the FDA does
not have a process in
place for approving
generic biologics (or
biosimilars). AARP and
a host of other organizations lobbied Congress intensely during
the health care debate, calling for legislation that would allow
the FDA to approve
such a process.
WE HAVE GENERICS
FOR CHEMICAL
DRUGS. WH Y NO T
FOR BIOLOGICS?
The primary point of
contention has been
the period of exclusiv-
ity. The pharmaceuti-
cal industry has asked
for at least 12 years of
exclusivity before a
generic biologic is
allowed, arguing that
the steep cost of de-
veloping a new bio-
logic medicine ($1.2
billion) and the
lengthy time it takes a
drug manufacturer
to go through the
research-and-
development process
(roughly ten years)
warrant this period of
exclusivity. AARP and
others have argued
that drugmakers typi-
cally recoup the costs
of developing biologic
drugs within three
years, and that the
time to develop a bio-
logic is only slightly
longer than that re-
quired to develop a
chemical drug, so the
exclusivity period
should be limited. The
Federal Trade Com-
mission (FTC) recent-
ly released a report
saying that a 12- to 14-
year exclusivity period
would actually dis-
courage drugmakers
from developing new
drugs, and that a
shorter exclusivity pe-
riod is needed to bring
down prices. “These
drugs are both very
important and very
expensive and may
become more impor-
tant in the future,”
says John Rother, vice
president and director
of policy and strategy
for AARP. “In order for
the people who need
them to have access
to them, we need to
make them more
affordable.”
HO W MUCH COULD
GENERICS SAVE?
Not as much as generic equivalents of
chemical drugs (which
reduce prices by up to
80 percent). That’s
because we currently
lack the technology to
duplicate biologics exactly, so any biosimilar
drug would still need
to go through clinical
trials in humans before
being approved, which
could add millions in
development costs.
Still, the FTC predicts
that biosimilars will
save consumers 10 to
30 percent over
brand-name biologics.
Current government
estimates say biosimilars could save Medicaid and Medicare $9
billion over ten years.
