Biosimilars

Biosimilars


Welcome to this quick guide
on Biosimilars. Cancer patients may soon be
hearing about and offered new
treatment options
called biosimilars. This quick guide will explain
what biosimilars are and how
they are being used to treat
certain types of cancer. There are different types of
drugs used to treat cancer. Some, like chemotherapy,
are made from chemicals. Others, called biologics,
use living organisms. A biologic can be made from
living cells or tissues, like
a vaccine. Or it can be made by
living cells or tissues, like many of the newest
cancer therapies. Biologic drugs are complex. Because they are made by
living organisms, it is
impossible to make an
exact copy of one. In fact, even different batches
made of the same biologic drug
aren’t exactly identical. Biologic drugs (also called
biological drugs or
biopharmaceuticals) aren’t
only used to treat cancer. Vaccines and insulin used to
treat diabetes are made with
living organisms. Some treatments for arthritis,
psoriasis, Crohn’s, and
colitis are too. One of the most well-known
biologic drugs used to treat
cancer is Trastuzumab
(brand name Herceptin®), which is used for HER2-positive
breast cancer and gastric
cancer. Another biologic that treats
cancer is rituximab (brand
name Rituxan®), which is used
for blood cancers. Bevacizumab (brand name
Avastin ®) may be used to treat
breast, colorectal, lung, and
other cancers. Cetuximab (brand name Erbitux ®)
is used for colorectal and head
and neck cancers. So now that we know what biologc
drugs are, what are biosimilars? A “biosimilar drug” is a copy
version of a biologic drug. It is given at the same dose,
for the same purpose, and works
in the same way as the
original biologic drug. But unlike generic drugs (which
are exact copies of chemical
drugs), biosimilars are not
exact copies. They are so similar to the
original biologic, that
biosimilars work the
same way in your body. But because biologic drugs are
made by or from living organism,
it is impossible to make an
exact copy of one. Instead, biosimiliars are made
to be very similar copies of
biologic drugs. The Food and Drug Administration
(FDA) is the federal agency
responsible for
protecting public health and ensuring that drugs are
safe and effective. It oversees the approval of all
drugs, biological products, and
medical devices in the U.S. -including generics and
biosimilars. Before the FDA will approve
using a biosimilar, it must
undergo a series of tests. These tests make sure that the
biosimilar has the same overall
structure and function as the
original drug. The FDA also requires
biosimilars to be made at the
same dose and strength as the
original biologic product. The biosimilar product must: Meet FDA’s rigorous standards,
Be made in licensed facilities,
and be monitored to ensure
quality. Biosimilars must work just as
well (they cannot be worse…
or better) and be just as safe
as the original biologic
product. To know if a drug is a
biosimilar, it helps to
understand the way
drugs are named. Every drug that’s offered to a
patient has a trademarked brand
name and a generic name. Let’s use Tylenol as an example Tylenol is a brand name for a
chemical drug whose “generic”
name is acetaminophen. The “generic” name is what is
used by the medical industry to
define what the drug does and
how it reacts within the body. No matter what company makes
this drug, the “generic” name
will always be “acetaminophen” even though only one company
can use the brand name
“Tylenol.” A biosimilar drug will have
the same “generic” name as
the original drug -but it will be followed by a
dash and a series of
four letters. In 2015, the FDA approved the
first biosimilar drug for use
in the U.S. It is called filgrastim-sndz
(brand name Zarxio®), and it is a biosimilar to the
drug filgrastim (brand
name Neupogen®). Both Zarxio® and
Neupogen ® are used to help
patients produce the white
blood cells they need to
fight infection. They are both approved for
cancer patients receivin
chemotherapy, a stem
cell transplant, or who have severely low levels
of white blood cells for
other reasons. They both work the same. Your doctor will prescribe
Zarxio® OR
Neupogen®. Pharmacists can switch out a
generic drug for a brand
name drug. But they can’t give you a
biosimilar instead of a
prescribed biologic product, without getting your provider
to write a new prescription. This means if your insuranc
company will only pay for the
biosimilar and the original
drug is prescribed, the pharmacist must ask your
provider to change the
prescription to the specific
drug that your insurance
will cover. You can ask your doctor or
pharmacist whether you are
receiving an original reference (or “brand name” product),
a generic product, or a
biosimilar. When you become more familiar
with how treatments work and
how drugs are named, you can feel more confident
about the care you receive. Although biosimilars are fairly
new in the US, they have
been approved and used safely
in Europe since 2006. In the United States, the price
savings of using biosimilars
over the original product are
still somewhat unclear. The hope is that biosimilars
may improve a patient’s access
to care, increase treatment
options, and possibly offer
price savings. Let’s hear Dr. Leah Christl
from the FDA talking about
the future of biosimilars
in cancer treatment. I think there’s a lot more
that’s coming for cancer
patients in that space and we have a
number of development programs
to cancer therapies that
are ongoing. I expect that we’ll receive more
marketing applications,
which will hopefully lead to more approvals for cancer
therapies and again, have that competition in the
marketplace which will
hopefully drive down costs
for health care.

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