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The New 180 Days? Humira Biosimilar Deals Give Amgen 150-Day Jump On Samsung

 
• By Sue Sutter

If approved in the US, Samsung Bioepis' adalimumab biosimilar may launch June 30, 2023, five months after the market entry date for Amjevita under Amgen's agreement with AbbVie; the 150-day marketing advantage for the first biosimilar approved suggests a benchmark for future patent litigation settlements.

Pages of a calendar

AbbVie Inc.'s agreements resolving Humira (adalimumab) patent litigation with biosimilar developers set a 150-day marketing exclusivity benchmark for future settlements involving first and subsequent filers of 351(k) applications to the same reference biologic, just one month short of the statutory 180-day exclusivity awarded for small molecule generics.

Under a deal announced April 5, Samsung Bioepis Co. Ltd. would be able to launch SB5, its proposed biosimilar to Humira, on June 30, 2023 in the US. That date is 150 days later than provided in AbbVie's September 2017 settlement with Amgen Inc., which allowed for a Jan. 31, 2023 launch of the latter's Amjevita (adalimumab-atto)

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