AbbVie wards off another Humira biosim challenger with Fresenius Kabi settlement

AbbVie has inked several patent deals over the last year to defend its top drug, Humira, but the company isn’t done quite yet. On Thursday, the drugmaker reached its latest patent resolution, this time with Fresenius Kabi, establishing launch timelines for the biosim developer if it can secure approvals.

Under the deal, Fresenius will license AbbVie’s Humira patents and pay royalties for the ability to market its biosimilar. The biosim maker can launch in Europe upon approval and in the U.S. on Sept. 30, 2023, contingent on an FDA nod. The companies are keeping quiet on the precise deal terms.

Fresenius Kabi acquired Merck KGaA's biosimilar portfolio last year for €156 million upfrontplus up to €500 million in milestonesand submitted its Humira biosim to European authorities in December.

The deal follows others by AbbVie with biosim makers Amgen, Samsung Bioepis, Mylan and Novartis. Under those deals, Amgen gets the earliest U.S. launch date in January 2023, followed by Merck in June, Mylan in July and Sandoz in September. Meanwhile, Humira biosims from Amgen and Novartis hit European markets this week.

At least one biosim player has resisted making a deal with AbbVie. Boehringer Ingelheim is hitting back against an AbbVie patent suit by arguing that the Illinois drugmaker pursued overlapping and noninventive patents.

Humira was the world’s bestselling drug last year, generating $18.4 billion globally and about 66% of AbbVie’s total sales for the year. AbbVie has dozens of patents protecting the key drug, making it tough for biosim makers to litigate and reach the market without settling patent lawsuits.

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Analysts have predicted that Humira's sales could peak at $21 billion before biosims dig in. In a recent report, EvaluatePharma predicted the drug would lead industry sales in 2024 with global revenues that year of $15.3 billion.