Licensing and prescribing biosimilars in Australia
Journal Title: Generics and Biosimilars Initiative Journal - Year 2013, Vol 2, Issue 3
Abstract
Some years ago, Australian regulatory authorities decided to follow the path laid down by the European Medicines Agency in adopting a process for approval of biosimilars. This has been a largely successful process, resulting in the licensing of biosimilars for many peptides, especially epoetin and granulocyte colony-stimulating factor (G-CSF). Aside from the availability of multiple agents, pricing has been significantly affected by the ability of hospital pharmacies to tender for supply of a particular drug, restricting choice in their hospitals to one of a number of agents with identical or similar pharmacodynamics and mechanisms of action. Increasingly, however, patients are opting to have supplies of these expensive drugs delivered by community pharmacies. This has the potential to dilute cost savings and increase the complexity of pharmacovigilance.
Authors and Affiliations
David A Power
Keywords
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- EP ID EP354907
- DOI 10.5639/gabij.2013.0203.030
- Views 113
- Downloads 0
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