UP FRONT
Advanced Practice Voices
In this section, nurse practitioners, pharmacists, physician assistants, and
other advanced practice providers discuss issues specific to their practices –
from implementing quality improvement initiatives to staying up-to-date in
the latest hematologic advances.
In this edition, Beth Faiman, PhD, MSN, APRN-BC, AOCN, addresses the
use of biosimilars in hematology/oncology.
Biosimilars in Hematology:
A Work in Progress
Recently, I was reviewing editorial content for
ASH Clinical News, when I came across an ar-
ticle covering the U.S. Food and DrugAdminis-
tration’s (FDA’s) approval of emicizumab-kxwh,
which was indicated for prevention or reduc-
tion of the frequency of bleeding episodes in
patients with hemophilia A. Naturally, because
of the “-kxwh” drug extension, I assumed that
emicizumab-kxwh was a biosimilar version of
emicizumab. Since Europe is far ahead of the
U.S. in terms of the approval of and experience
with biosimilar agents, I was excited to learn
that another biosimilar agent finally was ap-
proved for use in the U.S. 1
My joy quickly turned to confusion when
I learned that this drug was not a biosimilar
agent, but a biologic product. Two questions
popped into my head: “When did the naming
of biologics change?” and “How could I not
know about this?”
If I had questions about biosimilars, it
made me wonder what questions other pro-
viders might have about biosimilars. What is
the state of biosimilars and biologic agents in
the U.S.? Has the global impact of biosimilars
changed? Does the medical community feel
confident enough to use these drugs in their
clinical practice?
In this column, I hope I can answer these
questions – and help you answer questions
from patients – about the similarities and
differences between biosimilar and biologic
drugs in hematology.
The Same, but Different
In December 2017, ASH Clinical News ran
a series of articles reviewing important and
TABLE.
relevant concepts about biosimilars, including
immunogenicity, extrapolation, manufactur-
ing, and economic impacts. In the past year,
the science of biologics and biosimilars has
continued to move ahead rapidly, and now,
in December 2018, U.S. practitioners have 14
biosimilar agents available for use, including
four hematologic products (see TABLE ).
ASH Clinical News readers likely are famil-
iar with the key concepts of biosimilar drugs
and their reference products, but to quickly re-
view: A biosimilar is a biologic product that is
similar (but not identical) to a biologic product
already approved by the FDA (also known as
the “originator” or “reference product”). 2
Biologic agents are developed from living
organisms, which can include bacteria, yeast,
or even human cell lines, and unlike traditional
medications, they cannot be made through
synthetic chemical processes.
Biologics and biosimilars share features –
such as a particular mechanism of action and a
common amino acid sequence – but biosimilars
are not identical copies of originator products.
Each product is marked by differences in its host
FDA-Approved Biosimilar Agents and Their Indications
Drug Name /Approval
ASHClinicalNews.org
Providers have many questions about
biosimilars: What is the state of biosimilars
and biologic agents in the U.S.? Has their
global impact changed? Does the medical
community feel confident enough to use
these drugs in their clinical practice?
Class
Indication
Zarxio (filgrastim-sndz)
Approved March 2015 The first human-made form
of granulocyte colony-
stimulating factor (GCSF), a
biosimilar to Neupogen Numerous indications mirror the Neupogen
prescribing information (as most biosimilars do)
Nivestym (filgrastim-aafi)
Approved July 2018 The second biosimilar to
Neupogen Approved for all eligible indications of the
reference product
Retacrit (epoetin alfa-epbx)
Approved May 2018 The first biosimilar to epoetin
alfa Indicated for patients with anemia from chronic
kidney disease, chemotherapy, or zidovudine
treatment for HIV infection has received
Also approved for use before and after surgery to
reduce patients’ risk of needing transfusions
Udenyca (pegfilgrastim-
cbqv)
Approved November 2018 The first pegylated biosimilar
in hematology and medical
oncology Indicated for patients with chemotherapy-
induced neutropenia
cell line, protein structures, and manufacturing
processes. Despite the structural and functional
differences that can emerge in the manufactur-
ing of a biosimilar product, the FDA mandates
that there are “no clinically meaningful differ-
ences in terms of safety and effectiveness from
the reference product” and only minor differ-
ences in the clinically inactive components. 2
An interchangeable product is a biosimilar
product that meets additional requirements
showing that the drug is expected to pro-
duce the same clinical result as the reference
product in any given patient and the agent can
be substituted for the originator without any
involvement from the prescriber. As of yet,
no biosimilars have been approved with this
designation.
Patients and providers may inaccurately
refer to biosimilars as generic drugs because
these drug classes share a common goal –
providing patients with equally effective but
less expensive versions of branded or biologic
agents. However, generic drugs follow a specific
blueprint, and manufacturers can replicate a
branded agent’s chemical structure.
In the case of biologics and biosimilars, it is
impossible for biosimilars to follow a standard
manufacturing scheme, given their complex
protein structures and differences in host cell
lines. Thus, biosimilars are not generic drugs,
nor are they intended to replace a reference
product. 3
Biosimilars on the World Stage
The global impact of biosimilar drugs is dif-
ficult to quantify, and the economic benefit is
even more difficult to measure. This is due, in
part, to the glaring fact that only a handful of
biosimilars are approved for use in the U.S. The
approvals cover a wide swath of indications,
and, unfortunately, there are only five approved
biosimilars in the hematology space.
Continued on page 38
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