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 something beyond the current approved Australian biological name (the INN where available) is required for Australia.
The TGA puts this naming initiative in the broader context of policies “to encourage update of biosimilar medicines” in Australia, including the 2015 Biosimilar Awareness Initiative, and recent 2017-2018 budget initiatives supporting biosimilar update in Australia. Click here for further information.
Naomi Pearce
Principal Lawyer, Patent Attorney, Trade Mark Attorney
Naomi is listed in IAM Patent 1000 as one of Australia's leading patent litigators, and in IAM Strategy 300: The World's Leading IP Strategists. Underpinning Naomi’s legal work is a deep understanding of the pharma/biopharma industries, resulting from first hand experience and knowledge as VP of IP in-house at global pharma giants, and Partner of a top-tier international law firm.
