Biosimilars

Biosimilars (Inflectra®, Renflexis®, Brenzys®, Erelzi®, Riximyo®)

There’s another option that is now available to treat inflammatory arthritis: biosimilar medications. You may have seen this term in the news, or even heard your doctor or nurses mention it. Biosimilars work the same way as biologics, but they are created and approved for use in different ways.

What Are Biosimilars?

As original biologic brand patents expire very close copies of these (known as biosimilars) are now coming onto the market. However, they are not like tablet-form generic medications (which are 100 per cent identical to the original brand-name medication). Biosimilars use the research already completed by the original biologic manufacturer and build on this, so they require comparatively less time and clinical trial data to receive approval.

This means they are more cost-effective to produce than the original biologic (sometimes called the reference biologic or originator) medication, so they will generally provide a cost-saving to the Australian Government. The cost savings allow the government to invest in other areas of the healthcare system.

Consumers are expected to benefit from the increased range of treatment options available to them. However, both biologics and biosimilars are supplied at a fixed rate to consumers through the Pharmaceutical Benefits Scheme (PBS).

Are Biosimilars Safe To Use?

All biosimilars have to meet the same standards of safety and efficacy as any other prescription medication approved by the Therapeutic Goods Association (TGA). Biosimilars made by different manufacturers can safely differ very slightly from the original product and from each other.

How Will I Take My Biosimilar?

Biosimilars are taken in the same way as their reference medication (including how they are used before, during and after pregnancy). They have the same possible side effects, contraindications and monitoring tests.

Which Biosimilars Are Available in Australia?

Once approved, biosimilars have registered (®) brand names of their own. However, Australia does not have a naming convention for biosimilars at this stage. This means you will see the original medication name followed by the brand names for both the originator biologic and its subsequent biosimilars. For example, if you looked up etanercept, it could be listed as Enbrel®, Brenzys® or Erelzi®.

Currently, there are several biosimilars that have been approved for use in Australia by the TGA to treat some forms of inflammatory arthritis. Of these, the biosimilars that are currently subsidised through the PBS are:

  • Infliximab (Inflectra®, Remsima®, Emisima®, Flixceli®, Renflexis®)
  • Etanercept (Brenzys®, Erelzi®)
  • Rituximab (Riximyo®)

‘A’ Flagging of Biosimilars

Just as brands of synthetic medications can be substituted with their generic counterparts, so too can original brands of biologics be substituted with their equivalent biosimilars at pharmacy level, without checking with the prescriber. This process is known as ‘A’ flagging.

As a result, when you take your prescription to the pharmacy, you could be given either the original biologic OR the biosimilar equivalent without you or your doctor being told UNLESS your prescribing doctor has ticked the ‘Brand Substitution not permitted’ box at the top of the prescription. If your doctor has ticked this box, your pharmacist must dispense the brand you have specified (either the biologic or the biosimilar).

About Switching Biologics And Biosimilars

There are three ways you can be prescribed a biosimilar medication:

  • If you have not previously been treated with a biologic medication and there is an approved biosimilar, your treating doctor may prescribe either the reference biologic medication or its corresponding biosimilar.
  • If you have been treated with a biologic medication from a specific classification (such as a TNFi biologic) and that medication did not work well for you, you could be prescribed a biosimilar from a different classification. For example, if you had tried Enbrel® (etanercept) for rheumatoid arthritis and it did not work for you, your doctor may prescribe Riximyo® (rituximab) for you instead.
  • If you have been treated successfully with a biologic medication, your doctor can switch you from the reference medication to its biosimilar, or between biosimilar brands of the same reference medication.

Studies have shown that there is no increased safety risk to patients when switching between biologics and biosimilars. However, it is important that you and your rheumatologist discuss this based on the most up-to-date knowledge to determine what is best for you.

 

This information is part of CreakyJoints Australia’s comprehensive guide for patients living with rheumatoid arthritis. Learn more or download your free copy of Raising the Voice of Patients: A Patient’s Guide to Living with Rheumatoid Arthritis in Australia today.