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CONTINUING PROFESSIONAL DEVELOPMENT
Australian Pharmacist Continuing Professional
Development (CPD) is a central element of PSA’s
CPD & PI program.
The CPD section is recognised under the PSA
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questions they answer.
CPD credits are allocated based on the length of
the article and the complexity of the information
presented. A minimum of 6 out of 8 questions, 4 out
of 5 questions, or 3 out of 4 questions correct is
required for the allocation of Group 2 CPD credits.
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1. Which ONE of the following
statements in relation to biosimilars
a) Biosimilars are an identical duplicate of
the reference biological medicine.
b) Biosimilars have a demonstrable
similarity in physicochemical, biological
and immunological characteristics,
efficacy and safety to an already
registered biological medicine
c) Biosimilars are an identical duplicate of
the reference traditional small-molecule
d) None of the above.
2. Which of the following statements
in relation to ‘bioequivalence’ and
‘biosimilar’ medicines is CORRECT?
a) Biosimilar medicines are another name
for generic medicines.
b) A brand is deemed to be a biosimilar to
a reference brand when the original-
generic ratio and 90% confidence
interval for the area under the plasma
concentration-time curves (AUCs) lie
between 0.8 and 1.25.
c) A bioequivalent medicine and the
reference medicine will share the same
amino-acid sequence but may have
differences in other aspects (e.g. protein
d) None of the above.
3. Which of the following statements
is CORRECT? Brand substitution
between the biosimilar brand and
the reference brand is permitted
a) The patient agrees to the substitution.
b) The brands are identified in the PBS as
c) The prescriber has not indicated on the
prescription that brand substitution is
d) All of the above.
4. Which ONE of the following
statements in relation to biological
medicines and biosimilars is
a) Biological medicines are associated with
a possibility of immunogenicity as the
human immune system can recognise
the product as foreign.
b) An immunogenic response can manifest
as an allergic reaction.
c) The immune response triggered by a
biosimilar will be the same as that from
a reference brand.
d) The effects of immune responses can
be a slow occurring process, so effective
and comprehensive post-marketing
surveillance is essential for safety
5. Which ONE of the following
statements in relation to the supply
of biosimilars is CORRECT?
a) Biosimilars can be substituted for other
biosimilar brands or the reference brand
they do not need to be ‘a-flagged’ on
b) Trials have demonstrated multiple
switching between biosimilar and
reference brands to be no different in
terms of safety and effectiveness in the
c) The ability to easily distinguish between
reference and biosimilar brands is
important for facilitating timely and
effective pharmacovigilance programs
and adverse effect reporting for
d) All biosimilars on the PBS are ‘a-flagged’
with the reference brand.
12. Australian Government Department of Health.
Pharmaceutical Benefits Scheme. Infliximab. At: www.pbs.
13. Australian Government Department of Health.
Pharmaceutical Benefits Scheme. Basaglar insulin glargine.
In: Public summary document (PSD) – March 2015 PBAC
meeting. 2015. At: www.pbs.gov.au/info/industry/listing/
14. Generics and Biosimilars Initiative. Possibility of substitution
of biosimilars in Europe. 2013. At: www.gabi-journal.net/
15. Generics and Biosimilars Initiative. France to allow
biosimilars substitution. 2014. At: www.gabi-journal.net/
16. Generics and Biosimilars Initiative. New Jersey passes
biosimilars substitution bill. 2015. At: www.gabionline.
17. Generics and Biosimilars Initiative. Update on US state
legislation on biosimilars substitution. 2015. At: www.gabi-
18. Lim D, Siegel E, Sunderland VB, et al. A QUM approach
to regulating biosimilars in Australia. National Medicines
Symposium (21–23 May 2014) – Medicines in health:
shaping our future. Brisbane: NPS MedicineWise.
19. Australian Government Department of Health. Biosimilar
Awareness Implementation Framework. At: www.
20. Australian Government Department of Health.
Pharmaceutical Benefits Scheme. Factsheet – Biosimilar
infliximab on the Pharmaceutical Benefits Scheme. 2015.
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