Biosimilars are coming: ready or not

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.

The Breakthrough of Biosimilars: A Twist in the Narrative of Biological Therapy

“…Furthermore, these high costs restrict the availability and accessibility of such drugs to only those who can afford them. Certain countries, such as Australia, have responded to these high costs by limiting the administration of biologics to only indications that receive reimbursement through their Pharmaceutical Benefits Scheme (PBS) [8]. However, issues, such as formulary inclusions, drug availability, and patient out-of-pocket costs still imply that access to biologics treatment still remain limited in several developing and even certain developed countries.…”

Optimal cancer drug dosing in adolescents: new issues and the old unaddressed ones

“…27 Female AYA had higher rates of toxicity (neutropenia, anaemia and febrile neutropenia episodes) and significantly better tumour response to chemotherapy (% necrosis at surgery), suggesting that using the same formulae for dosing women as men leads to higher drug exposure in women. This has recently been demonstrated in a pharmacokinetic study in doxorubicin clearance in AYA patients 28 and suggests that the survival gap between men and women may be explained by the under-dosing of male AYA patients.…”

Who is afraid of biosimilars? Openness to biosimilars in an Australian cohort of patients with rheumatoid arthritis

“…However, the high cost of biologic therapies poses a tremendous health economic challenge in Australia and worldwide . With several biologics reaching patent expiry and the end of exclusivity periods, there is an increasing development and adoption of biosimilar medicines, which have the potential to improve affordability and access to therapy . It is estimated that the Australian Government's annual spending of AU$2.2 billion on biologics could be decreased by up to 24% through the successful uptake of biosimilar medicines .…”

“…1 With several biologics reaching patent expiry and the end of exclusivity periods, there is an increasing development and adoption of biosimilar medicines, which have the potential to improve affordability and access to therapy. 2 It is estimated that the Australian Government's annual spending of AU$2.2 billion on biologics could be decreased by up to 24% through the successful uptake of biosimilar medicines. 3 Although the predominant focus of current literature has been on physicians' awareness and confidence of biosimilars, an effective introduction of biosimilars requires an understanding of patient attitudes of these medicines.…”