BENEFITS
Benefits of biosimilars
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, and one that is adapted to the patients’ particular conditions, needs, and preferences
Mike Scott PhD
Medicines Optimisation
Innovation Centre, Antrim,
Northern Ireland, UK
Despite some uncertainty surrounding the
bioavailability, onset of action, duration of
action, and adverse events of biosimilars, their
development and subsequent regulatory approval
these past years have been received with great
expectation, given the potential substantial gains
their use brings to health systems in general and
patients in particular. Although there has been
a rapid increase in the number of biosimilars
available worldwide recently, mainly in the fields of
oncology and rheumatology, their uptake has been
comparatively slow, which is in part due to lack of
knowledge of their benefits by the different
elements in the process of treatment decision
making. 1,2
Clinicians
Currently, the US Food and Drug Administration
24 | 2019 | hospitalpharmacyeurope.com
only requires proof of similarity to the reference
product in terms of structure and function, with
no significant differences in purity, safety and
efficacy. In the EU, the functional and structural
characteristics must be similar between the
reference biologic product and follow-on biosimilar,
and the pharmacokinetic, efficacy, safety and
immunogenicity data must be consistent for both
molecules. 2,3 Other countries might have less
stringent requirements for approval of a biosimilar,
and the subsequent post-marketing monitoring and
surveillance needs might differ as well. However,
given the unavailability of precise methodologies
to determine the structure of large biological
molecules, the standards applied to evaluate the
original molecules may not be appropriate to
evaluate the biosimilar copies. 1
These limitations can have a significant influence