Biosimilars in Australia – Patient Information 2017

Biosimilars are now available in Australia. We support the adoption of biosimilars and believe they hold great promise in lowering costs for patients and improving access to treatment options. However, we want to ensure they are implemented safely and effectively. We recommend that you inform yourself about biosimilars and their reference biologics as you may be prescribed one at some point. You can do this by talking to your treating doctor and pharmacist and reading information available from Government and reputable disease specific organisations.

What to say

It is important that you feel empowered in your role as a patient and have open communication with your doctor about your treatment options. You have CHOICES and should never feel as though your voice is not important. CreakyJoints Australia will always advocate for a safe and transparent environment for all patients and in the current landscape of biosimilars this is even more important.
These are our guiding principles we believe patients need to demand to achieve this:

As patients, we want…

  • The choice between being prescribed an originator biologic or its biosimilar.
  • Our physician and pharmacist to provide us with the information needed to make an informed decision.
  • To be notified of any substitution.
  • To participate in the cost savings that occur when choosing a biosimilar over a biologic (we are the risk takers).
  • To trust that what we’re being prescribed is safe and effective.
  • Evidence that switching back and forth multiple times between an originator biologic and its biosimilar is safe.
  • Medications to have distinguishable names for clarity at prescribing and dispensing stages so we have confidence about what we’re putting into our bodies and security knowing that if we need to report an adverse event, we are reporting accurately.
  • Our prescribing doctor to be notified of any substitution.
  • Our prescribing doctor to be able to prevent substitution.
  • Records to be kept by our prescribing doctor and pharmacist of any substitution.
  • Our physician to be able to quickly track which biologic or biosimilar medication we were given in the event of an adverse event, side effect, or change in our condition.
  • More appropriate access to biosimilars by relaxing eligibility criteria.

What to know

What are biologics?
A biologic medicine is a large molecule typically made from living cells and used in the treatment, diagnosis or prevention of disease. Biologic medicines include therapeutic proteins, DNA vaccines, monoclonal antibodies and fusion proteins. Biologic medicines are often 200 to 1,000 times the size of widely used small molecule drugs and are far more complex structurally. They are also highly sensitive, making them more difficult to characterise and produce.1

What are biosimilars?
Unlike generic medicines where the active ingredients are identical, biosimilars – by definition – are not identical to the originator biologic they mimic. This is due to the fact that biosimilars and biologics are grown rather than synthesized. They are similar, but not the same. Biologics made by different manufacturers can safely differ very slightly from the original product and from each other.2

Why are biosimilars important?
With expanding demand for good-quality healthcare, comes the challenge of controlling healthcare costs.
The safe and regulated introduction of biosimilars into the market has been forecasted to expand access to much needed biologic medicines and reduce costs.3

What is substitution?
When you take your biologic script to the pharmacy, you may be offered a biosimilar brand instead. It’s important that you discuss with your doctor if a biosimilar version of your biologic therapy is appropriate for you. They have the potential to save you money, but ultimately you and your physician should decide what is best for you. If you decide a biosimilar is not a good match for you, your doctor has the power to tick the ‘brand substitution not permitted’ box on your prescription, this means the pharmacist cannot substitute your medicine. It is important that you understand which medicine you have been prescribed by your doctor so you can be sure what you get at the pharmacy is correct.

What is switching?
Switching means changing between a biologic and a biosimilar and vice versa. For example: you may have been taking a biologic for some time and then be prescribed the biosimilar of that medicine. There is concern that switching and especially multiple switching over time can have an effect on the immunogenicity of the therapies. In the absence of robust switching studies, we must be cautious about switching; triggering an immune response or causing the medicine to be less effective. Since immune responses can take a while to surface, it makes it much harder to work out which product is causing the problem. This is why it’s critically important that patients and physicians are aware of a switching or substitution should they occur.

What is A-Flagging?
Medicines, such as biosimilars that are deemed equivalent to their originator can be given the term ‘a-flag’ by Australia’s Pharmaceutical Benefits Advisory Committee (PBAC). This means they can be substituted by a pharmacist in consultation with the patient.

What is indication extrapolation?
Indication extrapolation allows for the approval of a biosimilar for diseases or conditions for which it has not been studied, based on its similarity to an approved innovator biologic medication. This is a big part of what allows biosimilars to be cheaper. Biosimilar companies can skip the steps of testing every indication for safety and efficacy with expensive clinical trials. Extrapolation is necessary but the Therapeutic Goods Administration (TGA) must proceed with caution when considering extrapolation of indications. CreakyJoints Australia does not support automatic indication extrapolation of every indication the reference product is licensed to treat. CreakyJoints Australia does support extrapolation for additional indications if sufficient scientific justification for extrapolating clinical data has been clearly provided. In particular, data should address possible differences in immunogenicity and expected toxicities among sensitive patient populations, as well as the mechanism of action in each condition.

To download a pdf version of this information please click here.

  • 1. U.S. Food and Drug Administration. What are biologics: Questions and Answers. U.S. Food and Drug Administration. [Online] April 14, 2009. [Cited November 20, 2013]
  • 2. European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1).
    European Medicines Agency – Europa. [Online] May 24, 2012. [Cited: November 20, 2013.]
  • 3. Mellstedt, H., et. al. The challenge of biosimilars. Annals of Oncology 19. March 2008, pp. 411-419.