Because biosimilars and their reference biologic medicine are not identical, whether compared to each other or even between biosimilars, it is important to know which product has been used.
The ongoing lack of certainty about what is required to obtain biosimilar registration in Australia extends to three key issues:
- Comparability: is the new product sufficiently similar to permit it to rely on the reference product's safety and efficacy, data?
- Extrapolation: for which of the indications of the reference biological will the biosimilar receive marking authorisation?
- Interchangeability: should the new product be substitutable for the reference product in clinical practice and, if so, in what circumstances?