Biosimilars are coming: ready or not

摘要

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