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CONTINUING PROFESSIONAL DEVELOPMENT
information, e.g. education support
programs. Healthcare professionals also
need to be responsive to addressing any
patient questions or concerns.
Biological medicines are associated
with a possibility of immunogenicity
as the human immune system can
recognise the product as foreign.
This is can manifest as an allergic
reaction, or the body can generate
a low level of neutralising antibody
that eventually results in the loss of
activity of the biological medicine.
Cross-reactivity between the biological
medicines with naturally occurring
biological substrates can also trigger an
autoimmune response, and the immune
response triggered by a reference brand
may differ from that of a biosimilar.
Furthermore, effects of immune
responses can be a slow process, so
effective and comprehensive post-
marketing surveillance is essential for
Substitution of biosimilars has been
proposed as one of the strategies
for achieving savings for the PBS.2
Therefore, from a cost perspective,
allowing substitution of ‘a-flagged’
biosimilars introduces competition
to the biological medicines market.
For instance, the listing of Inflectra
triggered a reduction in the price the
government has to pay for the medicine.
This has meant the government can
afford to make it available to a larger
patient population, and also helps with
keeping the cost of the PBS sustainable.
There is no brand price premium on the
reference brand, so the cost to patients
with Medicare entitlements is still the
Potential implications of
As more biosimilars become increasingly
available and the likelihood of ‘a-flagged’
biosimilars increases, pharmacists
should actively provide education to
the public and ensure patients are able
to make an informed decision about
substituting ‘a-flagged’ biosimilars. The
Australian Government Department
of Health has developed a Biosimilar
Awareness Implementation Framework
to improve awareness and confidence
around the use of biosimilars.
with traditional small-molecule
medicines, brand substitution is not
always appropriate for some patients.
Regardless of the practice setting,
pharmacists have a professional
responsibility and duty of care to
their patients to ensure quality use of
medicines (QUM), and that substituting
one brand for another does not put
patients at risk. The Pharmaceutical
Society of Australia (PSA) Guidelines for
pharmacists on PBS brand substitution
(July 2004) supports and assists
pharmacists to make a professional
judgment about brand substitution.
The PSA guidelines encourage
pharmacists to avoid ‘multiple-
switching’ between brands to avoid
patient confusion. As biosimilars are not
completely identical to the reference
brand, multiple-switching between a
reference brand and biosimilar, and
between biosimilars is an interesting
‘watch this space’. Most of the available
trials to date demonstrate one-time
switching between the reference
brand and the biosimilar to be safe and
effective, but data is still lacking on
impact of multiple switching between
Another consideration which has been
highlighted is around the naming
conventions and proposals have called
for biosimilars to have a uniquely
identifiable name so the products from
different manufacturers can easily be
identified.8 Australia uses a biological
naming convention which does not
have a specific biosimilar identifier
suffix. The ability to easily distinguish
between reference and biosimilar
brands is crucial for helping to prevent
medicine misadventures such as
prescribing errors, and to facilitate
timely and effective pharmacovigilance
programs and adverse effect reporting.
Recent changes to the TGA guideline on
biosimilars encourage manufacturers
to include a brief description in their
product information to identify that
their biosimilar product name is a
biosimilar medicine to the named
Mrs Landsdowne’s case
Mrs Landsdowne appreciates the time
you have taken to explain the difference
between biosimilars and generic
medicines to her. You also explain there
are two brands of infliximab (Remicade
and Inflectra) subsided by the government
on the PBS. As with generic medicines,
the regulatory authorities have deemed
the two brands to be comparable enough
in terms of safety and effectiveness,
so the brands may be substituted. You
also provide her with a copy of the
Department of Health Pharmaceutical
Benefits Scheme (PBS) Biosimilar medicines
– fact sheet for patients and consumers,
and Factsheet – Biosimilar infliximab on
the Pharmaceutical Benefits Scheme, 20
and show her what the factsheets cover
so she can make an informed decision
as to whether she wants to switch to the
biosimilar infliximab the next time she
went back to the doctor to receive the
1. Australian Government Department of Health.
Pharmaceutical Benefits Scheme. Biosimilar medicines –
factsheet for patients and consumers. 2015. At: www.pbs.
2. Australian Government Department of Health.
Pharmaceutical Benefits Scheme. Biosimilar medicines –
factsheet for healthcare professionals. 2015. At: www.pbs.
3. Rossi S, ed. Australian medicines handbook. Adelaide:
Australian Medicines Handbook; 2015.
4. Australian Government Department of Health. Therapeutic
Goods Administration. Acronyms and glossary. 2015. At:
5. Australian Government Department of Health. Therapeutic
Goods Administration. Evaluation of biosimilars: what is a
biosimilar? 2015. At: www.tga.gov.au/book-page/what-
6. Australian Government Department of Health. Therapeutic
Goods Administration. Australian Register of Therapeutic
Goods (ARTG). 2015. At: www.tga.gov.au/australian-
7. NPS MedicineWise. Generic medicines: same difference? In:
NPS News; 2006. At: www.nps.org.au/__data/assets/pdf_
8. McKinnon R, Ward M. Biosimilar insulins: process, policy
and practical interpretations. Australian Pharmacist
9. Schellekens H. Biosimilar therapeutics – what do we need
to consider? NDT Plus 2009;2(Suppl 1):i27-i36. At: www.ckj.
10. Generics and Biosimilars Initiative. Biosimilars approved in
Europe. 2016. At: www.gabionline.net/Biosimilars/General/
11. Australian Government Department of Health.
Pharmaceutical Benefits Scheme. Brand premium policy.
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