What are biosimilar medicines?Wednesday, 9 October 2019
What are biosimilar medicines and how do they relate to biological medicines?
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 market).
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 health outcomes.
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 to the Government of the latter is usually much lower. There is no difference in cost to the individual.
How is the safety of a biosimilar medicine monitored?
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 U-100, more commonly known under the brand name Lantus (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. As of 11 October 2019, Semglee only is available under the Pharmaceutical Benefits Scheme (PBS), see http://www.pbs.gov.au/medicine/item/11815W.
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 nurses.
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 switching insulins.”
The ADS, ADEA and DA have developed a joint Position Statement (which can be found here).
Who chooses whether a biosimilar medicine is used?
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 pharmacy?
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