UP FRONT
Advanced Practice Voices
Continued from page 31
Further, complex pharmacoeconomic analy-
ses are required to measure the potential effect
of biosimilars, both locally and globally. The
literature on this topic is scarce, with few papers
relevant to the hematology market. Economists
and drug manufacturers seem eager to cash in
on the promises of marked price savings and
reduction in health-care costs if more biosimilar
drugs are prescribed for use in the clinic.
A RAND Corporation analysis estimated
that the potential cost savings could reach $54
billion over 10 years based on recent avail-
able data, but the actual savings “will hinge
on industry and regulatory decisions, as well
as potential policy changes to strengthen the
biosimilar market.” 4
Before those savings are realized, health-
care plans and insurance payers need to “buy
into” biosimilars, recommending them for their
hospital formulary. Yet most of what has been
reported in terms of cost savings are estimated
projections of the potential effect of the drugs
on various U.S. markets. Many factors, such as
physician or practitioner uptake of biosimilar
drugs, availability of biosimilar drugs, and
skepticism around competitive pricing, will
ultimately decide how biosimilars will be used
in clinical practice.
name with a hyphen ( FIGURE ). 7
Also, the suffix cannot be false or mislead-
ing, contain or suggest any drug substance
name or core name, look similar to or other-
wise connote the name of the license holder,
or be too similar to any other FDA-designated
nonproprietary name suffix.
This was a departure from the original
naming convention, when the four-letter suffix
attached to the nonproprietary name signaled
the biosimilar’s manufacturer (as with Sandoz’s
filgrastim-sndz) and distinguished the biosimi-
lar agent from its reference product.
Whether the new process clarifies or
confuses remains to be seen, but more than 70
groups, led by the Alliance for Safe Biologics,
already submitted a letter to the FDA request-
ing the agency reinstate “meaningful” suffixes. 8
Implications for Practice
Large hospitals and commercial payers gener-
ally are responsible for making the decision to
switch a patient from a biologic to its bio-
similar drug, but advanced practice providers
(APPs) typically are the ones “on the frontlines”
with patients. APPs often are responsible for
prescribing biosimilar drugs and monitoring
the patients who receive them and, as a con-
sequence, field questions
about safety and costs.
Practitioners have the
largest experience with bio-
similars to the granulocyte-
stimulating factor filgrastim
in the setting of hemato-
poietic cell transplanta-
tion. A recent analysis of
published studies by the
World Marrow Donor As-
sociation (WMDA) showed
no evidence of a higher
risk of filgrastim antibody
formation using filgras-
tim biosimilars. 9 Based on
these findings, the WMDA
recommended that stem cell donor registries
use filgrastim biosimilars for the mobilization
of peripheral blood progenitor cells in healthy
donors, provided that they are approved by
national and/or regional agencies.
Because the currently available hemato-
poietic growth factor biosimilars are supportive
care agents, rather than agents intended to
treat a cancer, these drugs are less likely to raise
concerns for patients. If biosimilar versions of
targeted chemotherapies are approved by the
FDA in the future, this might change.
As APPs, our goal should be to educate
patients and peers about the similarities and
differences between biosimilars and their refer-
ence products, including if there are any differ-
ences in handling, administration, and storage
of the agents.
In my experience, I have not encountered
a single patient who has been fearful of the
transition to a biosimilar. Rather, most patients
seek the provider’s opinion about what is the
best drug for them. Navigating a cancer diag-
nosis is difficult enough for most patients and
their caregivers; determining which supportive
care agent to use remains less of a concern.
No biosimilar products are
approved as interchangeable
for their reference products,
but analyses suggest that the
biosimilars are often so similar
to the originator that these
drugs should be a standard
part of our practice.
For readers who are wondering about the
approval of a biosimilar version of rituximab,
this issue is still on hold. Novartis and San-
doz’s GP2013 candidate appeared the closest
to approval, until the FDA rejected the agent’s
biologics license application. In November
2018, the pharmaceutical manufacturers an-
nounced they had decided “not to pursue” a
U.S. biosimilar for rituximab. 5 The previous
month, however, the FDA’s Oncologic Drugs
Advisory Committee unanimously voted to
recommend approval of CT-P10, another
rituximab biosimilar candidate. 6
The Name Game
Now back to the question that prompted my
reflection: When did the naming of biologics
and biosimilars become indistinguishable from
biologic agents? Apparently, in January 2017.
In a guidance document for industry (“Non-
proprietary Naming of Biological Products”),
the FDA laid out strict suggestions about the
naming of biosimilars: The proposed suffix
should be unique, devoid of meaning, and in-
clude exactly four lowercase letters of which at
least three are distinct and attached to the core
38
ASH Clinical News
Biologic and Biosimilar
Naming Conventions
FIGURE.
Core name FDA-designated suffix
• no recognizable meaning
• 4 letters
• all lowercase letters
alfa -epbx
bevacizumab -awwb
filgrastim -sndz
filgrastim -aafi
Thanks to the rising costs of health care
in today’s climate, hospitals and consumers
are interested in cost savings. No biosimilar
products are approved as interchangeable for
their reference products, but analyses suggest
that the biosimilars are often so similar to the
originator that these drugs should be a stan-
dard part of our practice. Time will tell if the
projected dramatic cost savings are realized. If
nothing else, these drugs provide more options
for patients and providers. ●
REFERENCES
1. Kos IA, Azevedo VF, Neto DE, Kowalski SC. The biosimilars journey: current
status and ongoing challenges. Drugs Context. 2018;7:212543
2. FDA. Biosimilar and interchangeable products. Accessed November 8,
2018, from https://www.fda.gov/Drugs/DevelopmentApprovalProcess/
HowDrugsareDevelopedandApproved/ApprovalApplications/
TherapeuticBiologicApplications/Biosimilars/ucm580419.htm.
3. Cai XY, Wake A, Gouty D. Analytical and bioanalytical assay challenges to
support comparability studies for biosimilar drug development. Bioanalysis.
2013;5:517-20.
4. Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United States:
initial experience and future potential. Rand Health Q. 2018;7:3.
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will focus on robust biosimilar portfolio for unmet access and sustainability
needs. November 2, 2018. Accessed November 8, 2018, from https://
www.sandoz.com/news/media-releases/sandoz-decides-not-pursue-us-
biosimilar-rituximab-will-focus-robust-biosimilar.
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Accessed November 8, 2018, from https://www.fda.gov/downloads/
AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/
OncologicDrugsAdvisoryCommittee/UCM622649.pdf.
7. FDA. Nonproprietary Naming of Biological Products: Guidance for Industry.
Accessed November 8, 2018, from https://www.fda.gov/downloads/drugs/
guidances/ucm459987.pdf.
8. RAPS. 70 groups call on FDA to revert back to meaningful suffixes for
biosimilar names. May 12, 2016. Accessed November 8, 2018, from https://
www.raps.org/regulatory-focus%E2%84%A2/news-articles/2016/5/70-
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9. Pahnke S, Egeland T, Halter J, et al. Current use of biosimilar G-CSF for
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December 2018