Hosp Pharm 2015;50(10):847848

2015 Thomas Land Publishers, Inc.

www.hospital-pharmacy.com
doi: 10.1310/hpj5010-847

Guest Editorial
Biosimilars: Whats in a Name?
Anne P. Kim, PharmD, MPH, MIT*

he importance of drug names has already been

evidenced worldwide. A survey on biologics
was conducted by Fernandez-Lopez et al1 to
gather the opinions of a small number of pharmacists
involved in the Academy of Managed Care Pharmacy
(AMCP), the American Society of Health-System Pharmacists (ASHP), or the American Pharmacists Association (APhA). Seventy-seven responding pharmacists
indicated that they were more familiar with biosimilars
(51; 66.2%) than with interchangeables (39; 50.6%).
Of 75 pharmacists, 56 (74.6%) reported being confident or very confident with substituting an originator
with an interchangeable if the drugs shared the same
nonproprietary name. However, only 28 (37.3%)
pharmacists felt confident or very confident in substituting an interchangeable that had a unique suffix distinct from the originator.
In Europe, biosimilars are not given unique
names. Similar to how small molecule generic drugs
in the United States adopt the same international
nonproprietary names (INNs) as their corresponding
brand reference drugs, European biosimilars share
the same INNs.2 These INNs are designated globally by the World Health Organization (WHO) for
all medications (including biosimilars), but different countries can choose whether to adopt the INN
or establish a different name.1 For example, Europe
assigned the same INN for a biosimilar to epoetin
alfa, whereas Australia introduced the same biosimilar as epoetin lambda.1 In an effort to reduce confusion, WHO has since developed an initiative to add
biologic qualifiers (ie, a 4-letter code) to keep track of
the biological products manufacturer and manufacturing site.1
The US Food and Drug Administration (FDA)
recently proposed a naming system for biological
medications that is reminiscent of what the WHO
has established. For biosimilars, the FDA proposed
that a unique 4-letter suffix be added to the INN.
For interchangeables, the FDA requested comments
on the following options: (a) same name allow the

original manufacturing company to choose a unique

4-letter suffix at the time of approval, which would
then be assigned to future interchangeables; or (b)
different names allow a new manufacturing company tochoose and keep a unique 4-letter suffix distinct from the original reference drug (ie, originator).3
Although the comment period closed on October 27,
2015, comments can still be submitted to the FDA,
according to 21 CFR 10.115(g)(5). The comment
submission due date simply allows the FDA to gather
comments prior to drafting a final version of the
guidance for industry.4
Until the FDA presents the final guidance on the
biosimilar naming system, there are areas of concern
for which health care providers can begin preparing.
CONCERN OF CONFUSION
With different names for biosimilars (and perhaps for interchangeables), it will be essential to know
how to access and use the Purple Book. Published in
September 2014, the Purple Book lists all biological
medications with notations on which medications are
considered originators, biosimilars, and interchangeables. For all intents and purposes, the Purple Book is
the biological Orange Book and may be used in the
same manner as the Orange Book to determine which
biological medication is biosimilar to or therapeutically interchangeable with an originator.3
CONCERN OF DIFFERENCE
Biosimilars are not exact replicas of the originator, so health care providers need to decide whether
specific biosimilars will be considered preferred drugs
of choice or whether therapeutic interchange protocols will be acceptable for biosimilars, especially if
they have been approved as interchangeables. Discussions regarding whether switches should be discouraged for patients who have finally been stabilized on
a particular biosimilar may be necessary, as there are
no data and further research is required.

Resident, Drug Information Center, College of Pharmacy, Washington State University Spokane; e-mail: anne.kim@wsu.edu

Hospital Pharmacy

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Guest Editorial

CONCERN OF DATA
Pharmacy and Therapeutics (P&T) Committees
generally use clinical trial data to support formulary
and protocol decisions, so the lack of data will be a
major obstacle. Even with the current governmentinitiated trial in Norway, this biosimilar study is only
observing the effects of switching from Remicade to
an infliximab biosimilar (regardless of indication).5,6
Health care providers will need to hold discussions
about the appropriateness (or inappropriateness) of
extrapolating the studys findings to all other biologic
medications and their respective biosimilars.

Pharmacists will likely play a major role in transitioning to an era with biosimilars and interchangeable drugs since pharmacists interface with providers
and patients as well as health insurance companies.
Keeping abreast of the developments in the field of
biologics will soon become a necessary asset for all
pharmacists.

CONCERN OF SAFETY
Due to the potential risk of increased immunogenicity as well as a possible risk for hypersensitivity associated with switching between biosimilars,7
it will be important to consider requiring meticulous
documentation of biologic therapy initiation, interchanges, and discontinuations. Given the high probability of discontinuity of information amongst the
different health care fields, it will be important to
ensure that a biosimilar switch occurring at a community pharmacy will translate into proper documentation at the prescribers clinic, for example.

2. Chandra A, Vanderpuye-Orgle J. Competition in the age

of biosimilars. JAMA. 2015;314(3):225-226.

CONCERN OF ERROR
Implementing an electronic database that is
designed to distinguish which drugs are originators,
biosimilars, and interchangeables may help reduce
the risk of medication errors. Despite proper use of
legend symbols, unique database characteristics will
need to be considered. For example, how long does the
drug name field need to be if drugs are in a lphabetical
order and the biological INN is long, followed by a
4-letter suffix? Should the 4-letter suffix come before
the INN and be alphabetized accordingly to avoid
accidentally choosing the wrong biosimilar?

5. The NOR-SWITCH study. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02148640. Updated April 2015.

Accessed September 3, 2015.

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Volume 50, November 2015

REFERENCES
1. Fernandez-Lopez S, Kazzaz D, Bashir M, McLaughlin
T. Assessment of pharmacists views on biosimilar naming
conventions. J Manag Care Spec Pharm. 2015;21(3):188-195.

3. Nonproprietary naming of biological products guidance for industry. FDA Web site. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM459987.pdf. Published April 2015. Accessed
August 28, 2015.
4. US Food and Drug Administration. Nonproprietary naming
of biological products. Draft guidance for industry; availability.
https://www.federalregister.gov/articles/2015/08/28/2015-21383/
nonproprietary-naming-of-biological-products-draft-guidancefor-industry-availability. Published August 28, 2015. Accessed
September 4, 2015.

6. Stanton D. Norway to facilitate switch to biosimilars

with $3m Remicade study. BioPharma-Reporter. http://www.
biopharma-reporter.com/Markets-Regulations/Norwayto-facilitate-switch-to-biosimilars-with-3m-Remicadestudy. Published December 6, 2013. Accessed September
3, 2015.
7. Feldman SR. Inflammatory diseases: Integrating biosimilars into clinical practice. Semin Arthritis Rheum. 2015;44
(6 suppl):S16-S21.