Biosimilars and biologics: What you need to know
The advent of biosimilars heralds a new era in biologic therapy for auto-immune forms of arthritis. But government moves to drive the uptake of biosimilars to achieve budget savings have raised concerns. What does it all mean for health consumers?
Biologic medicines for the treatment of auto-immune forms of arthritis have been available in Australia since 2003. These medicines have helped to revolutionise the treatment of conditions such as rheumatoid arthritis and juvenile arthritis, reducing disability and improving quality of life for many.
The patents for many biologics used for arthritis are now starting to expire in Australia and copies, known as biosimilars, are beginning to enter the market. A biosimilar of infliximab, the first for a biologic used to treat arthritis, has just been approved for use and subsidy in Australia, and will be available soon. Other biosimilars are expected to come onto the market in the next couple of years.
The introduction of biosimilars has been widely welcomed because it offers the potential to reduce costs for both the health consumer and the Government, so more people may be able to start using these medications. Biosimilars will also increase treatment choices for people who need to take biologic medicines.
Less welcome, however, are measures which will allow pharmacists to substitute a biosimilar for the original biologic medicine, as they do with generic medicines. This means that your pharmacist may in fact give you a biosimilar medicine (if available) rather than your usual biologic without you or your doctor realising.
These measures are designed to encourage the uptake of biosimilars with the aim of achieving budget savings for the Federal Government but have raised concerns among consumer and clinician groups about the implications for consumers.
Arthritis Australia and the Australian Rheumatology Association in particular have been active in raising their concerns with the Federal Government about allowing pharmacy level substitution for biosimilars.
Why is pharmacy level substitution a concern?
Associate Professor Susanna Proudman, Medical Director of Arthritis Australia, explains why allowing substitution at the pharmacy level might be a problem.
“Biosimilars are copies of biologic medicines but they are not generics. Biologic medicines are grown in living cells and are extremely complex. They are virtually impossible to copy exactly, unlike generics of simple conventional medicines such as aspirin.
“This is really important because minor differences in these medicines and the way they are produced and administered, may affect their safety and effectiveness,” she says.
“We know that biosimilars are safe and effective in patients who are new to that therapy and we support their use in these cases.
“At present however, we just don’t have enough evidence to know if biosimilars and biologics can be used interchangeably in people who are stable on their current therapy, as could happen if pharmacy level substitution was allowed. This is especially the case for auto-immune forms of arthritis, where the use of biosimilars is still quite new,” A/ Professor Proudman says.
“Switching and especially multiple switching between a biosimilar and a biologic, may affect patient safety by triggering an immune response or it may make the medicines less effective. If something does go wrong, it also makes it much harder to work out which product is causing the problem, because an immune response can take a while to surface.”
“For these reasons it is important that consumers are informed about biosimilars and talk to their rheumatologist about whether these medicines are suitable for them.”
5 things you can do to make sure you get the right medicine
Both prescribers and consumers will still have the right to veto biosimilar substitution at the pharmacy level, but it is important that this is an informed choice. To make sure you get the right medicine:
1) Talk to your rheumatologist about your biologic medication and whether a biosimilar is available and might be right for you.
2) Decide in consultation with your rheumatologist whether you should keep taking the same brand of biologic/biosimilar medicine or whether it could be substituted.
3) If you both decide that you need to keep taking the same brand of medication, make sure your rheumatologist ticks the ‘Do not substitute’ box on your script. Tell your pharmacist that you want the medication that is on the script and that you do not authorise any substitution.
4) Check the package of your medication when you collect it from your pharmacist and keep a record of its name so you know what brand of medicine you are taking.
5) Keep informed about this issue by visiting www.arthritisaustralia.com.au
What does this mean?
A complex medicine grown using living organisms.
A copy of a biologic medicine that is very similar, but not identical to, the original medicine.
A simple, chemically manufactured medicine, such as aspirin.
An identical copy of a conventional medicine.