IP Australia is inviting submissions by 17 November 2017 on the first wave of IP reform initiatives arising from the Government's response to the Productivity Commission Report on 25 August 2017. Life sciences...
Eleven years after the launch of the first biosimilar product in EU, we are now in a position to calibrate our biosimilar market expectations with market experience, rather than extrapolating them using educated...
In a case relating to patents for global blockbuster biologic Humira™ (Adalimumab), the Full Federal Court has drawn a bright line around the limitations of the PTE regime in Australia, excluding from eligibility swiss...
This afternoon, the Australian Government released its response to the report of the Productivity Commission Inquiry into IP released 20 December 2016. In its 25 page response to the 752 page Productivity Commission...
Just over a week ago, the US Federal Circuit provided BPCIA “dance lessons” for reference product sponsors and biosimilar applicants, as it handed down its decision in Amgen v Hospira, the third of the Amgen “trilogy”...
The TGA consultation paper can be found here. The TGA paper outlines the biosimilar naming conventions implemented in EU (INN), Japan (BSn), and the planned US 4 letter biologics suffix, and seeks input on whether...
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