Biosimilars are coming: ready or not.

摘要: Biosimilars have had a sizeable impact on the availability and use of biologic medicines in Australia, particularly those prescribed for supportive care oncology or to treat inflammatory diseases. drugs that modify disease processes are likely be next 'wave' biosimilars receive regulatory approval, both internationally Australia. Given their more tailored development pathway relative reference biologics, biosimilar versions these potential reduce substantially burden healthcare system increase patient access treatment. However, there is some uncertainty regarding approval expected clinical characteristics among Australian physicians. This review outlines concept biosimilarity details leading biosimilars. It also highlights benefits patients system, as well opportunities stemming from The framework rationale underlying extrapolation indications others held by originator biologic, absence comparative study, described. In addition may bring, Australia's established cooperative trial group programmes afford an opportunity further innovation providing mechanism expand certain new indications.