Biosimilars Explained

A medicine might have a biological origin or a chemical origin. When medicines are new they are usually patented so that the original brand can recover their research and development costs. When a chemical medicine comes off patent, 'generics' are often developed and sold that are as safe an effective as the original brand. A biosimilar medicine is a 'very similar' version of an original biological medicine that is as safe and effective as the original brand. Biosimilars and generics play an important role in ensuring that the PBS is sustainable.

Biological medicines are grown and purified from cell cultures and include vaccines, growth factors, immune modulators, monoclonal antibodies, and blood products. While older biologics like insulin and growth hormone have been around for decades, there has been a recent increase in the number of available biological medications. In 2019/2020, biological medicines accounted for 7 of the top 10 medications by expenditure on the PBS.

Biosimilar medicines are versions of already registered biologic medicines that are very similar but not identical, unlike generic medicines that use the same active ingredients as the original. The complex process of making biological medicines makes it impossible to create an exact copy of the original, and even batches from the same manufacturer can vary due to natural variability in the manufacturing process.

Biosimilars are safe and effective, meeting the same regulatory standards as their counterparts. According to the GBMA, they deliver over $200M in savings to the PBS each year, which can be re-invested in the PBS, making it more sustainable and allowing more medicines to be covered for patients.

The use of biosimilars can increase cost-effective treatment options for patients. The "nocebo effect" can negatively impact patient outcomes due to negative perceptions of a treatment. However, healthcare professionals showing a positive attitude towards biosimilars and patient education can help to reduce the nocebo effect. As more biologic meds go off-patent, biosimilars offer a great opportunity to reduce the burden on the PBS and ensure a healthy future for generations.