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

Will Australia follow the US and prohibit the patenting of genes and biological material?

A decision is expected later this year from the Australian High Court in D’Arcy v Myriad Genetics Inc. This case is essentially equivalent to the US Myriad Supreme Court case and thus will provide a definitive judgment in relation to the patentability of isolated genes in Australia, which the lower courts have unanimously found to