are biosimilar medicines and how do they relate to biological
Biosimilar medicines are very similar, but not identical,
versions of an already registered biological medicine (also called
the reference biological medicine, which is the first brand to
Biological medicines, including biosimilar medicines, contain
one or more active substances that are derived from living cells or
organisms. Biological medicines are not referred to as generic
medicines, because the processes used to produce these medicines
are naturally variable. Just like no two people are ever identical,
no two batches of a biological medicine, including biosimilar
medicines, are ever exactly the same (even if produced by the same
manufacturer). Insulin is an example of a biological medicine.
Biosimilar medicines that are approved by the Therapeutic Goods
Administration (TGA) have been tested extensively and, although
some minor differences may be present, they have been shown to be
as safe and effective as the registered biological medicine.
Overall they are used to treat the same diseases, in the same way,
as the registered biological medicine and hence they have similar
The dose and dosage regimen of biosimilar medicine will not
change, because they are designed to be given at the same dose and
dosage regimen as their reference biological medicine. One main
difference between the registered biological medicine and the
biosimilar medicine is that the cost of the latter is usually much
How is the safety of a biosimilar medicine
Manufacturers must develop a risk-management plan before any
biological medicine is released to market. This plan is assessed by
the TGA. Once the medicine is on the market, the TGA continues to
monitor its performance for safety, effectiveness and quality, with
a particular focus on adverse effects.
Pharmaceutical companies are required to report any adverse
effects that they are aware of. These adverse events' reports can
also be made by health care professionals, consumers or carers. The
reports are placed in a database (the Australian Adverse Drug
Reaction Reporting System), and this database is checked regularly
by the TGA.
Biosimilar insulin in Australia
Currently Insulin Glargine, more commonly known under the brand
name Lantus or Toujeo (produced by Sanofi-Aventis) is the only
insulin available in Australia as a biosimilar. The Therapeutic
Goods Administration (TGA) has approved two biosimilar formulations
of insulin glargine:
- Basaglar, produced by Eli Lilly
- Semglee, produced by Alphapharm
The Pharmaceutical Benefits Advisory Committee (PBAC) is
considering the PBS listing and use of biosimilar insulins.
If one brand of medicine can be exchanged for another by the
pharmacist, they are 'substitutable'. This means pharmacists can
substitute between brands in consultation with you, but without
needing to refer you back to your doctor. Substitution between
brands of biological medicines is also considered by the
Pharmaceutical Benefits Advisory Committee (PBAC).
Even if a medicine is substitutable, your doctor can tick the
'brand substitution not permitted' box when writing a prescription.
If this box is ticked, by law the pharmacist cannot dispense a
brand other than that prescribed.
At this stage the Australian Diabetes Society (ADS), the
Australian Diabetes Educators Association (ADEA) and Diabetes
Australia (DA) are strongly opposed to allowing pharmacists to to
offer biosimilar insulin substitutions because of potential safety
issues. They support substitution of insulins only under
appropriate medical supervision and with the involvement of the
diabetes healthcare team including diabetes educators and practice
They go on to say that "pharmacy level substitution has the
potential to seriously disrupt diabetes management for large
numbers of people with diabetes. We have particular concerns about
the increased risk of hypoglycaemia which may be associated with
The ADS, ADEA and DA have developed a joint Position Statement
(which can be found here).
Who chooses whether a biosimilar medicine is
The medicine used for your treatment is a choice that is made by
you and your doctor.
What you can expect when you go to the
If you and your doctor choose a biosimilar insulin it is
important to note that the appearance of your medicine may change,
depending on the particular brand you choose. The way in which the
medicine is used may also be different, but the active ingredient
does not change.
You can discuss how best to use your medicine with your doctor,
pharmacist or nurse.
Need more information?
The Biosimilar medicines: the basics - information for
consumers and carers brochure is aimed at consumers and
will help you by answering some common questions. It can be
downloaded from here.
You can also find more information on the Australian Government Department of Health
Biosimilar Awareness Initiative webpage.
You should discuss any further questions that you may have about
biosimilar medicines with your healthcare provider.
Written by Carolien Koreneff, CDE-RN, FADEA