Biosimilar development is not for the faint hearted. The time and costs involved in R&D, clinical, and regulatory are exorbitant, and the patent barriers to launch are...
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...
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...
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...
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...
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...
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...
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