Biologics and biosimilars not 'identical' - why it matters

Bowel Cancer Australia

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In Australia, 15,000 people receive a bowel cancer diagnosis each year and despite improvements in screening, approximately 20% of patients diagnosed with bowel cancer already have metastatic disease at the time of diagnosis.
In addition, 30 – 50% go on to develop metastatic disease within 2 – 2.5 years.

Alongside standard chemotherapy, the introduction of targeted biologics has significantly expanded the treatment options for advanced bowel cancer, also known as metastatic colorectal cancer (mCRC).
Biologics are large, structurally complex medicines made from living organisms such as protein, bacteria or yeast. Their active ingredients are created by biological processes rather than chemical combinations.

Since the 1980s, hundreds of biological medicines have been approved for the treatment of diseases such as cancers, diabetes, heart attacks, rheumatoid arthritis, Crohn's disease and many more.

Around 300 new biological medicines are currently under development for the treatment of cancer and related conditions.

Biological medicines usually have more complex and larger structures than their traditional counterparts; for example, Aspirin, a chemical medicine, contains 21 atoms, while a biological medicine may contain more than 20,000 atoms.

As a result, biological medicines are more sensitive and are more likely to cause an immune reaction in the body than chemical medicines.

Once administered, a biological medicine can mimic the natural protein in a person, thereby helping to reduce symptoms and slow the progression of a disease.

Biological medicines, such as vaccines, can also prevent disease.

But what does it mean for bowel cancer patients?
The use of targeted biologics has been shown to delay disease progression and prolong overall survival for bowel cancer patients by a few more months.

However, the high price of targeted biologics restricts their accessibility, meaning that clinicians’ options become more limited and patients are denied access to potentially life-prolonging medications.

Access to a range of treatment options is important for metastatic bowel cancer patients where the choice of different treatments is already limited, which is why the introduction of biosimilars marks a new stage in biologic therapy.

However, understanding the difference between biosimilars and biologics is extremely important.

Switching, and especially multi-switching between biologics and biosimilars may affect patient safety by triggering an immune response or it may make the medicines less effective.

Biosimilars are not generics.

A generic medicine is a copy of brand-name medication that has exactly the same dosage, intended use, effects, side-effects, route of administration, risks, safety, and strength as the original drug.

In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts.

A biosimilar medicine is a very ‘similar’ version of an already-approved biological medicine, in terms of its characteristics, quality, safety and efficacy; however, it is not identical.
While biosimilars have an important place in the medicines landscape, there are concerns.

While the differences between biologic medicines and their biosimilar counterparts may be minor, even small variances in medicines and the way they are produced and administered can affect their safety and effectiveness.

Because biosimilars remain fairly new, there has been little testing to determine if biosimilars and biologics can be used interchangeably in people who are stable on their current biologic therapy.

If there is a negative reaction, it is also more difficult to determine which product caused the problem because an immune response can take a while to appear.

Talk to your doctor or oncologist to learn more about biological and biosimilar medicines, if they are suitable for you, and any potential side effects.

Over the next few years, we expect to see a wave of biosimilar medicines available in Australia as patents for the original biological medicines start to expire.
Bowel Cancer Australia will continue to monitor developments on the availability of biosimilar medicines and any new evidence of how they may impact bowel cancer patients.
Changes to biosimilar prescribing policy are being considered by the government as part of discussions with the medicines industry, as it develops a new five-year strategic agreement.

Mandatory prescribing of biosimilars to previously untreated patients is just one option being considered in an effort to increase uptake of biosimilars.

Keep informed about this issue and any changes that result following the upcoming budget announcement by visiting https://www.bowelcanceraustralia.org/surgery-treatment/biological-and-biosimilar-medicines.
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