Biologic and biosimilar medicines
Biologic medicines have become an important part of modern healthcare. They include familiar products like vaccines, insulin to treat diabetes, hormones such as human growth hormone, and many modern drugs used to treat cancer, arthritis and other auto-immune disorders.
Unlike most traditional medicines that are made through chemical processes, biologic products are made of, or from, living things like yeasts, bacteria or animal cells. They usually have a more complex molecular structure than other prescription drugs.
Small changes in the manufacturing process of biologic medicines can lead to changes in the medicine produced. Because biologics are made from living things, there can even be small differences between different batches of the same medicine. This variability is a common, inherent part of all biologic medicines.
Competitor products of biologic medicines aren’t called generics, they are known as `biosimilars’. A biosimilar is a highly similar, comparable, version of an approved biologic medicine. Any differences between the biosimilar and its reference medicine will have been shown not to affect the quality, safety or efficacy of the medicine.
Before they can be used by patients, biosimilars need to be tested in clinical trials to establish their similarity to their reference biologic medicine. This approval process is conducted by regulators like the European Medicines Agency and, in New Zealand, Medsafe.
The high cost of some biologic medicines means that they are often not affordable. Biosimilars offer considerable potential for PHARMAC to increase competition, reduce costs, and improve access for patients to these important medicines.
Australia and New Zealand regulators have begun approving biosimilar medicines for use. From 2012 PHARMAC has funded a biosimilar form of filgrastim, a medicine used to treat low white blood cell count in people going through chemotherapy treatment, and in 2014 PHARMAC has funded a biosimilar of somatropin, a human growth hormone, and run a competitive process for infliximab, which is used for auto-immune conditions and inflammatory bowel disease.
Last updated: 2 May 2017