Switching from Biologic to Biosimilar: Australia’s Unique Approach

Switching patients from an originator biologic (the reference product) to a biosimilar version has been a topic of keen interest in recent years, both in Australia and globally, as more biosimilars have emerged onto the market. This trend has flowed from the expiration of data exclusivity and patent protection for a number of important originator

TGA transparency reforms (part 2): Early publication of major innovator prescription medicine applications

In Part 1 of this series (available here), we examined the impact of the proposal by Australia’s Therapeutic Goods Administration (TGA) to provide early confidential notification to innovators of applications under evaluation for generic and biosimilar product registration. In this Part 2, we focus on the TGA’s other proposed reform, the earlier publication of applications

TGA transparency reforms (part 1): Notification of generic and biosimilar medicines to impact pharmaceutical patent disputes in Australia

Regulatory changes recently approved by the Australian Government are likely to impact the way in which pharmaceutical patent litigation is conducted in Australia. The Therapeutic Goods Administration (TGA) is currently seeking feedback on options for implementing the proposed Prescription Medicines Transparency Measures by 9 June 2020. The reforms are directed at:   1. Early publication

Biosimilars in Australia

A ‘biosimilar medicine’ or ‘biosimilar’ is a highly similar, but not identical, version of an original biological medicine (‘reference medicine’) – a medicine comprised of large complex molecules derived in some way from a living organism.  In this sense, a biosimilar differs to some extent from a traditional small molecule “generic” medicine, which is commonly