AbbVie has already inked several patent settlements with biosimilar developers looking to take on its megablockbuster Humira, and now the company is back at the deal table with a fourth.
In a move that cheered AbbVie investors, Novartis' Sandoz unit struck an agreement to put off its biosim launch until 2023—a deal that forces the Swiss drugmaker to get in line behind other players for its U.S. launch.
Under the deal, Novartis will be able to launch its Humira biosimilar in Europe Tuesday, but the U.S. launch has to wait until September 2023.
Novartis becomes the fourth Humira biosim maker to settle with AbbVie. Under various deals, market watchers can expect staggered U.S. biosim launches in 2023. Amgen gets to launch in January of that year, followed by Merck in June, Mylan in July and now Sandoz in September. Several companies have set European launch dates of Oct. 16.
Amgen was the first company to ink a Humira biosim patent settlement last year.
AbbVie still faces at least one challenger, though. Boehringer Ingelheim has opted not to settle and instead is fighting AbbVie’s patent lawsuit. AbbVie sued Boehringer for infringing dozens of Humira patents, but in an “unclean hands” defense, Boehringer argues AbbVie acted inequitably by seeking overlapping and non-inventive patents. The case is still playing out.
Meanwhile, Humira continues to churn out industry-leading sales that totaled $18.4 billion last year. Analysts believe the drug will peak at $21 billion before U.S. competition hits. European competition should start to take a toll this month.
Aside from patent litigation, AbbVie faces whistleblower and class action lawsuits over alleged kickbacks. Last month, California’s insurance commissioner sued AbbVie alleging the company bought meals and shelled out cash to boost Humira scripts, plus used nurse “ambassadors” to go into patients’ homes and administer care. The suit also says AbbVie’s ambassadors didn’t pass patients' concerns back to doctors, in an effort to protect prescriptions.
This week, a law firm sued the company on behalf of investors alleging AbbVie failed to disclose those marketing tactics.
Editor's note: This story was corrected to note that BI is among other biosim challengers that haven't inked a settlement.