There is no
accepted
worldwide naming
convention for
biosimilars and
reference
biologics
with the manufacturer’s name would improve
pharmacovigilance and reduce the risk of transcription
and prescription errors, there are concerns that
meaningful suffixes could become a proprietary item
of the manufacturer associated with the product,
and that through mergers and acquisitions the actual
manufacturer might change while maintaining the
original suffix. However, it is unlikely that prescribers,
and to a lesser extent, patients, would remember
the correct INN with a suffix including four random
letters. Remembering the INN with the brand name or
the manufacturer seems more likely.
Other areas
In Japan, biosimilars are referred to by the non-
proprietary name of the reference biologic, followed
by BS to denote biosimilar, the respective follow-
on number and an abbreviation to reference
the manufacturer. 9 Because the value of any
distinguishable naming convention is dependent
on its uptake by end-users, Health Canada intends
to consult interested stakeholders to understand
the compatibility of different schemes with the
8 | 2019 | hospitalpharmacyeurope.com
electronic systems used for the prescribing,
dispensing and tracking of biologic drugs. In the
meantime, biologics in Canada are identified by
brand name, common or non-proprietary name,
and drug identification number. 10 India, China,
Colombia, and Mexico have marketed intended
copies of etanercept, and some Latin American
countries and India have approved and marketed
an intended copy from rituximab. There is no
homogenous naming convention, but the fact that
these intended copies often share the INN of the
original biologic and its biosimilars underscores
the need for a naming convention that allows their
differentiation. 11
Conclusions
Although there is a trend toward establishing
differentiation between biologic originators and
biosimilars through naming, there is still lack of
global consensus. This lack of harmonisation could
have direct implications on pharmacovigilance
data, monitoring interchangeability, automatic
substitution, and even reimbursement processes. 12
References
1 European Parliament and the
Council of the European Union.
Directive 2010/84/EU of the
European Parliament and of the
Council. https://eur-lex.europa.
eu/LexUriServ/LexUriServ.do?ur
i=OJ:L:2010:348:0074:0099:EN:P
DF (accessed October 2018).
2 Grampp G, Felix T.
Pharmacovigilance
considerations for biosimilars in
the USA. BioDrugs 2015;29:
309–21.
3 European Medicines
Agency. Biosimilars in the EU.
Information guide for heath
professionals. www.ema.
europa.eu/documents/leaflet/
biosimilars-eu-information-
guide-healthcare-professionals_
en.pdf (accessed October 2018).
4 World Health Organization.
Biological qualifier. An INN
proposal. www.who.int/
medicines/services/inn/WHO_
INN_BQ_proposal_2015.pdf?ua
=1 (accessed October 2018).
5 US Food and Drug
Administration. Nonproprietary
naming of biological products: A
guide for industry. www.fda.gov/
downloads/drugs/guidances/
ucm459987.pdf (accessed
October 2018).
6 World Health Organization.
International nonproprietary
names (INN) for biological and
biotechnological substances.
www.who.int/medicines/services/
inn/BioReview2016.pdf (accessed
October 2018).
7 US Department of Health
and Human Services Food
and Drug Administration.
Labeling for biosimilar
products. Guidance for industry.
www.fda.gov/downloads/
Drugs/GuidanceCompliance
RegulatoryInformation/
Guidances/UCM493439.pdf
(accessed October 2018).
8 Fernando-Lopez S. FDA
draft guidance on the naming
of biosimilars. BioDrugs
2015;29:323–5.
9 Mysler E et al. Clinical and
regulatory perspectives on
biosimilar therapies and
intended copies of biologics in
rheumatology. Rheumatol Int
2016;36:613–25.
10 Klein AV et al. Biosimilars:
State of clinical and regulatory
science. J Pharm Pharm Sci
2017; 20:332–48.
11 Macdonald JC, Hartman
H, Jacobs IA. Regulatory
considerations in oncologic
biosimilar drug development.
MAbs 2015;7:653–61.
12 Kos IA et al. The biosimilars
journey: current status and
ongoing challenges. Drugs
Context 2018;7:212543.