Biological cancer therapies like Avastin are
drugs made from living cells. Biosimilars,
short for similar biological medicinal
products, have a chemical structure that
is highly similar to, but not exactly the
same as, an approved biologic therapy. A
generic drug, in contrast, has all the same
active ingredients as a brand-name drug.
Generic drugs generally cost less than
their brand-name equivalents. The hope
is that biosimilars will also cost less. But
because biosimilars are more expensive
to manufacture than generic drugs, the
cost reduction may not be as substantial.
Generics are up to 80 percent less
costly for patients than brand-name
drugs, says Gary Lyman, a medical
oncologist at the Fred Hutchinson
Cancer Research Center in Seattle. He
says it is estimated that biosimilars will
cost about 20 percent less for patients
than the original biologic therapy.
Kelley Davenport, the director of corpo-
rate affairs at Amgen, Mvasi’s manufacturer,
says information about how much Mvasi
will cost or whether Amgen will offer
a patient assistance program to help
pay for the therapy is not yet available.
Genentech makes Avastin and offers a
patient assistance program for it.
To receive FDA approval for a bio-
similar therapy, a manufacturer must
present data from laboratory studies and
clinical trials showing the biosimilar has
In September 2017, the U.S. Food and Drug Administration (FDA) gave the green light to Mvasi (bevacizumab-awwb), making it the first biosimilar anti-cancer drug approved in the
U.S. Mvasi is similar to Avastin (bevacizumab) and was approved to
treat certain types of advanced brain, colorectal, lung, kidney and
cervical cancers that Avastin is also approved to treat.
FDA Approves First
Biosimilar Cancer Therapy
NEW PRODUCT EXPECTED TO BE LESS EXPENSIVE
a highly similar chemical structure to
and the same pharmacological behavior
as the approved biologic therapy. It must
also have the same safety and effectiveness. The first biosimilar product
to be approved for use in the U.S. was
Zarxio (filgrastim-sndz), in 2015. Like
Neupogen (filgrastim), it is used to
reduce the risk of infection from cancer
treatments that deplete white blood
cells. Unlike Mvasi, it is not an anti-cancer drug.
Despite FDA approval of Mvasi, it is not
yet clear when oncologists will be able
to prescribe it. That’s because Amgen is
engaged in a patent dispute with Genentech,
which claims producing and selling Mvasi
would violate many of its patents.
In many states, a pharmacist can substitute a generic for a brand-name drug
without the prescribing doctor’s permission. For biosimilar drugs, a doctor
must write the prescription for either
the original biologic or the biosimilar.
Whether oncologists will choose a biosimilar version of an anti-cancer drug
over the brand name is not yet known.
“People have gotten used to Avastin,
the brand name,” says Lyman. “Generally,
I would anticipate biosimilar [anti-cancer
drugs] would take a bit of time to gravitate to actual clinical practice and use on
a broad scale.” —CHRISTINA BENNE TT
TOBACCOʼS GLOBAL REACH
Of the 1. 1 billion people throughout the world who use tobacco products, close to
80 percent live in low- or middle-income countries. About half of these individuals will
die from cancer or other tobacco-related diseases. But their smoking will result in more
than personal harm: In low-income countries, tobacco addiction leads smokers to spend
up to 30 percent of their income on tobacco products, depleting family funds needed for
groceries, education and health care.
Action on Smoking and Health (ASH), a nonprofit based in Washington, D.C., works with the
World Health Organization to encourage countries to adopt comprehensive smoke-free laws
and health care services that include smoking cessation.
To find more information and facts about worldwide tobacco use, like the one at left, visit
the ASH website: ash.org. —SUE ROCHMAN
USED WITH PERMISSION OF AC TION ON SMOKING & HEALTH.
Between 1990 & 2009
DECREASED by 26%
in Western Europe
INCREASED by 57%
in Africa and the