Abbreviations and definitions

Page last updated: 23 March 2017

Term/Abbreviation Definition

Adverse effect

A negative side effect of a medicine. All medicines and vaccines can cause side effects. Side effects and other problems are also called adverse events, which are defined as unwanted and sometimes harmful occurrences from using medicines, vaccines or medical devices (these are known as therapeutic goods). Importantly, adverse events related to the use of a therapeutic good are not always caused by the therapeutic good itself.

Adverse drug reaction

A noxious or unintended response to a medicine. These reactions are distinguished from adverse effects by the fact that a causal association with a medicine is suspected.

Biological medicine

A medicine that contains one or more active substances that are made by or extracted from living cells or organisms. They are usually made of proteins that are naturally produced in the human body.

Biosimilar medicine

A medicine that is highly similar to a reference biological medicine. The reference biological medicine and the biosimilar medicine are marketed under different brand names. Biosimilar medicines are marketed once the patent on the reference biological medicine has expired.

Brand substitution

Is the practice of dispensing one brand of a medicine instead of another brand of the same medicine at the pharmacy level without needing to go back to the prescriber, but in consultation with the patient. Substitutable brands include reference brands (sometimes referred to as the originator or innovator brand), generic brands and biosimilar brands. Substitutable brands have been tested and shown to be as safe and work as well as each other, and to produce the same health outcomes.

Immunogenicity

The ability to cause an immune response in the body, such as hypersensitivity or an allergic reaction.

Indication extrapolation

Extending the efficacy and safety data from a condition which the biosimilar has been clinically tested in to other conditions for which the health outcomes for the reference biological medicine is established.

International Non-Proprietary Name (INN)

The INN is a unique name given to an active substance which is globally recognised and is public property. The INN is used to facilitate the identification of active substances and the INN system is managed by the World Health Organisation (WHO).

Patent

A government licence that gives the owner, for a set period of time, the sole right to market a product and to exclude others from making, using, or selling an invention.

PBAC

Pharmaceutical Benefits Advisory Committee

PBS

Pharmaceutical Benefits Scheme

Pharmacovigilance

The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any drug-related problem.

Reference biological medicine

The biological medicine that was the first brand to market.

Regulatory system

The system that regulates medicines, including assessing and monitoring their safety, patient benefit and manufacturing quality. In Australia, the regulatory system includes the work of the Therapeutic Goods Administration.

TGA

Therapeutic Goods Administration