AbbVie: Competitor Pricing, Humira Formulary Placement Will Dictate US Biosimilars Impact

Now just months away from the first US Humira biosimilar launch, analysts are asking AbbVie for specifics on expected revenue erosion. CEO Gonzalez said AbbVie aims for 90% formulary coverage in 2023.

Revenue report
AbbVie continues to work to maintain US access to Humira after biosimilars reach market • Source: Shutterstock

How AbbVie will perform financially once top-seller Humira (adalimumab) faces biosimilar competition has been an underlying question during every quarterly earnings call the pharma has convened since its split from Abbott Laboratories in 2013. But now, as that day draws closer in the US, analysts and investors are seeking specific answers.

During AbbVie’s third quarter 2022 earnings conference call on 28 October, CEO Rick Gonzalez said things are on track for...

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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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