AbbVie Sets Biosimilar Expectations As It Prepares To Take The Plunge On Humira
US Brand Erosion Expected To Be 37% In 2023; Amgen Adalimumab Pricing ‘Not A Surprise’
• By David Wallace
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AbbVie has set out its expectations for US biosimilar competition to Humira this year, predicting 37% brand erosion with pressures ramping up in the second half of 2023 as Amgen’s Amjevita is followed into the market by numerous other adalimumab rivals. Management also commented on pricing dynamics after Amgen offered a dual-discount strategy.
AbbVie is preparing for a sharp drop in Humira revenues • Source: Shutterstock
While it won’t be news to anyone that AbbVie is on the cusp of a massive drop in Humira (adalimumab) sales in 2023 – as US biosimilar competition bites in the wake of Amgen’s launch of its Amjevita (adalimumab-atto) version (Also see "Amgen Delivers On Launch Of First US Humira Rival – At A 55% Discount" - Generics Bulletin, 31 January, 2023.) – industry onlookers have now finally been given some specifics on exactly how the originator sees the year shaping up for the firm’s flagship immunology brand.
With global sales of Humira up by 2.6% to $21.24bn in 2022 – including $18.62bn in the US, representing a...
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An abbreviated licensure pathway for biologics was created by the 2009 Biologics Price Competition and Innovation Act. Biologics demonstrated to be biosimilar to or interchangeable with FDA-approved products can use the 351(k) biologics license application pathway. Biosimilars BLAs submitted under the 351(k) pathway have a 12 month user fee goal for FDA action. Updated weekly.
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