coverage can also exacerbate financial constraints
that result in differences in equality in access to
treatment and care. 2,3
In addition, the commercialisation of biosimilars
may extend the current indications of their
reference products. This can occur when the
reference product is approved for an additional
indication, which results in registration of this new
indication for the biosimilar without conducting
further clinical trials. This significantly reduces
the investment in time and resources in the
development of the biosimilar. However, this
process of ‘extrapolation’, which is usually done
when changes in the manufacturing process of the
reference products are introduced, is not widely
accepted when it refers to new indications, and may
not be applicable to all types of molecules. 2
Nonetheless, not all patients may agree with
a switch from branded drug to biosimilar, for
several reasons, and they should be informed that a
biosimilar may not be identical to the reference drug
and that close monitoring may be needed during
the transition process. 1 Moreover, with the increased
availability of biosimilars, these agents might be the
first choice in some cases, or even when a switch is
needed due to formulary changes. There is currently
a dearth of data in regard to the potential risks and
benefits of multiple switches and of alternating
between a reference biologic and its biosimilar.
Likewise, comparative studies of different switching
strategies with adequate power to evaluate non-
inferiority or equivalence between reference and the
corresponding biosimilar are lacking. 3
Payers
Considering the increase in costs associated with
26 | 2019 | hospitalpharmacyeurope.com
References
1 Blumer I, Edelman S.
Biosimilar insulins are
coming: The top 10 things you
should know. Postgrad Med
2014;126(3):107–10.
2 Zalcberg J. Biosimilars are
coming: ready or not. Intern Med
J 2018;48(9):1027–34.
3 Carrascosa JM et al.
Biosimilar drugs for psoriasis:
Principles, present, and near
future. Dermatol Ther (Heidelb)
2018;8(2):173–94.
4 Uhlig T, Guro LG. Reviewing
the evidence for biosimilars: key
insights, lessons learned and
future horizons. Rheumatology
(Oxford) 2017:56(supp 4):iv49–62.
5 Edelman S et al. Biosimilar
insulins are coming: what they
are, what you need to know.
Curr Med Res Opin 2014;30(1):
2217–22.
6 Mestre-Ferrandiz J et al.
Biosimilars: How can payers
get long-term savings?
Pharmacoeconomics
2016;34(6):609–16.
drug development in recent years, which have
translated into higher prices for payers and direct
consumers, insurers have long been considering
alternatives to costly drugs, the benefits of which
outweigh costs, that do not jeopardise safety
and clinical outcomes in the long term. As for
generic small-molecule drugs, the introduction
of biosimilars can contribute to substantial cost
savings, although at a reduced scale given the
complexity of the manufacturing process for
biologics and their copies. It cannot be ignored
that the availability of biosimilars at lower prices
might have an impact on the price of their reference
products. If they are widely used, biosimilars
can potentially lead to lower prices through
competition. 2,5
Moreover, biosimilars can create opportunities for
research on new agents and/or stimulate innovation
with existing molecules (for example, new cell lines
used to produce the biosimilar). The increasing
availability of biosimilar versions for the same
reference is an incentive for companies to promote
the advantages of their own biosimilars versus the
competitors, and may encourage the generation
of efficacy and safety data for new indications not
attributed to the reference molecule. 2
Current obstacles to a broader use of biosimilars
include insufficient funding and education and
variable approaches to healthcare management
across countries. Administrative barriers,
prescribing restrictions, and absence of well-defined
clinical criteria for the initiation, discontinuation,
and maintenance of biosimilars may also play a
role in limiting access to treatment. To circumvent
some of these difficulties, governments can create
incentives at the hospital and clinical level to
promote use of biosimilars. Support for monitoring
and pharmacovigilance programs are also valid
strategies that foster a competitive market,
resulting in price reductions, while increasing the
willingness of both clinicians and budget holders
to use lower-cost products whenever feasible. At the
pharmacy level, clear regulations for substitution
are needed, although automatic substitution is
controversial. 3,4,6
In order to determine the impact of biosimilars
on healthcare systems, real-world studies are needed
to examine the effect on budgets and resource
utilisation as well as on pricing practices resulting
from the use of biosimilars. High-quality outcomes
data will ultimately support the introduction
of substitution regulations and the update of
prescribing guidelines. 6
Conclusions
In summary, prescribers, as well as other health
professionals, payers, and patients, should be aware
of the potential advantages and disadvantages
of biosimilars in order to allow for an optimal
treatment plan, one that is adapted to the patients’
particular conditions, needs, and preferences.
Biologics used in the treatment of cancer and
inflammatory diseases have been available for
some time, but few studies have evaluated their
effectiveness in the real-world. Moreover, some
biologic agents may still have an overall high cost,
which limits their widespread and rapid uptake.
Therefore, increased awareness of these drugs and
how they are developed, as well as of the concept of
biosimilarity and the current regulatory framework,
by prescribers and allied healthcare professionals
can play a significant role in increasing confidence
regarding the use of these drugs, not only for
clinicians but also for patients.