• Naomi Pearce, Emily Bristow

Pearce IP BioBlast: w/e 04 December 2020

Significant biosimilar activities this week include:

  • 02 Dec 20, US: Boehringer Ingelheim filed a Citizen Petition asking the Commissioner of Food and Drugs to interpret the term 'strength' in s 351(k) of the PHS Act for parenteral solutions to mean 'total drug content'. The current interpretation does not allow a biological product to be licensed as a biosimilar and/or interchangeable product if there is any variation in inactive drug volume. BI has argued that the proposed interpretation may increase access to more affordable biosimilar and interchangeable biological products.

  • 01 Dec 20, US: US District Court Judge Leonard Stark refused to grant costs in the Coherus/Amgen (pegfilgrastim) matter. Coherus argued that fees were warranted because Amgen had pursued a baseless claim and appeal, intending to thwart competition.

  • 28 Nov 20: Shanghai Henlius Biotech reported positive results from Ph III trials of its biosimilar bevacizumab candidate.

  • 24 Nov 20: Novartis released its annual report 'Meet Novartis Management 2020'. In the report, Novartis announced that GP2411 (biosimilar denosumab candidate) has commenced Ph III trials. Novartis also indicated it plans to launch biosimilar adalimumab (in Australia and Canada) and natalizumab in 2021-2023 and denosumab in 2024-2026.

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