This is an audio guide about biosimilar medications, brought to you by CreakyJoints Australia.

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TRANSCRIPT

Audio Guide 1: Biosimilar Medications

This is an audio guide about biosimilar medications, brought to you by CreakyJoints Australia.

A biosimilar medication (also known as a “biosimilar”) is a very close duplicate of an original brand of biologic medication (or “biologic”). 

Biologic medications are developed from living cells and are used for a wide range of conditions including diabetes, chronic kidney failure and some types of cancer. They are often also prescribed to treat autoimmune conditions such as rheumatoid arthritis, psoriatic arthritis and Crohn’s disease.

You might already be using biologics such as etanercept (sold under the brand name Enbrel), infliximab (sold under the brand name Remicade) or adalimumab (sold under the brand name Humira) to help treat your condition.

Biologics have large complex molecular structures compared to tablet medications. (Picture a basketball next to a pea and you’ll get the idea.) As a result, they cannot be processed through the digestive system. Instead, they are injected or infused into the bloodstream.

Unlike the synthetically made generic versions of tablet-form medications (which are 100 per cent identical to the original brand-name medication), biosimilars are almost identical copies of biologics.

Biosimilars are made using the same research and materials as the original reference biologics they replicate. The manufacturing processes are also exactly the same. Biosimilars even have the same active ingredient name as their reference biologic, but they are sold under different brand names.

However, the end products can never be exactly the same as the original biologics, so they cannot be reproduced identically. Both biologics and biosimilars can even vary slightly between batches.

Does this mean biosimilars are safe?

Yes, they are. The very minor differences between a biosimilar and its reference biologic mean that the biosimilar has the same safety profile as the reference biologic. Both must go through the clinical trial process, although biosimilars can use some of the data from the clinical trials conducted for their reference biologic.

Biosimilars must also pass the same strict regulation processes of Australia’s Therapeutic Goods Administration. Biosimilars will not be approved if they don’t meet the same quality, efficacy and safety standards as their reference biologics.

Is there a cost difference between biologics and biosimilars?

While biologics are planned and developed from the ground up, biosimilars are based on biologic structures that already exist. This means they are more cost-effective to produce than their reference biologic so they can be sold to the government at a lower price. 

Additionally, every time a new biosimilar is launched, the price the PBS pays for ALL equivalent medicines in the category drops. For example, if a new adalimumab biosimilar is approved, the price to the PBS of the reference biologic HUMIRA plus other approved adalimumab biosimilars all drop to the same lower price.

In the long run, that means less expensive medicine as the cost savings allow the government to invest in other medications and areas of the healthcare system.

There is no price difference for consumers between biologics and biosimilars as these are sold at the same fixed price through the Pharmaceutical Benefits Scheme (PBS). However, consumers benefit from the increased range of treatment options available to them.

How are biosimilars prescribed?

Only rheumatologists and clinical immunologists are authorised to prescribe biologics and biosimilars in Australia. If you have autoimmune arthritis you will most likely see a rheumatologist to access either of these medication types. 

There are several ways you may be prescribed a biosimilar.

Firstly, if you meet the access requirements and have not previously been treated with a biologic medication  your rheumatologist may prescribe an appropriate biosimilar for you if there is an approved one on the market for your condition. Also, if you have tried a biologic or biosimilar of one active ingredient and it didn’t work for you, your rheumatologist may prescribe a biosimilar with a different active ingredient that you haven’t tried.

Second, you may receive a biosimilar brand if you have been treated with an original biologic brand of the same active ingredient (such as etanercept) and it has been successful. Your rheumatologist can simply specify the biosimilar brand name they use on your prescription. (This process is known as “switching”.)

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

It is important to note that biologics will never be switched for biosimilars at pharmacy level if your rheumatologist has ticked the ‘Brand Substitution not permitted’ box on the prescription form. This ensures your biologic won’t be substituted for its biosimilar unless your rheumatologist deems it safe.

Studies have shown there are no increased risks to patients switching between biologics and biosimilars of the same type of medication, although it is always best to speak to your rheumatologist about which options are best for you. 

For more information about biosimilars visit the Arthritis Treatments section of the CreakyJoints Australia website (creakyjoints.org.au/education/arthritis_treatment_options/). If you have any further questions regarding biosimilars and biologics in relation to your treatment, speak to your rheumatologist.