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

Diagnostic Testing for SARS-CoV-2: How governments, regulators and the laboratory-diagnostics industry are responding to the challenge

In this article we examine how standard polymerase chain reaction (PCR) based testing for the novel coronavirus (SARS-CoV-2) works, explore the new CRISPR-based tests under development and the new rapid point-of-care tests being rolled out, and consider the initiatives by governments and medical device regulators to fast-track the availability of SARS-CoV-2 diagnostic tests.   Diagnostic

Federal Court of Australia dismisses preliminary discovery application regarding biosimilar suspected of infringing manufacturing process patents

In the recent decision of Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd [2017] FCA 285 (21 March 2017), Justice Stephen Burley of the Federal Court of Australia has delivered an important decision dismissing an application for preliminary discovery of documents relevant to determining whether a registered biosimilar product might infringe one or more

Normal service resumed? – Swiss-style claims and extensions of patent term

The Australian Patent Office has issued recent decisions (ThromboGenics NV [2015] APO 44 and AbbVie Biotechnology Ltd [2015] APO 45) finding that an extension of patent term will not be allowed in respect of Swiss-style claims.   Background Marketing of pharmaceuticals in Australia requires approval by the Therapeutic Goods Administration and inclusion in the Australian

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