2020 sales: $19.8 billion ($16.1 billion in U.S.)
Key patent expiration: 2023
Ever since AbbVie inked its first Humira biosimilar settlement with Amgen back in September 2017, the industry has had its eye on 2023.
Each day, the mother of all biopharma patent expirations nears: Humira, the industry’s top drug by sales, is expected to face its first U.S. copycats in January 2023 under the deal between AbbVie and Amgen.
After Amgen launches its copycat, a who’s who of biosimilar entrants are lined up to make their debuts. In all, AbbVie has inked at least eight Humira biosimilar settlements, with the likes of Boehringer Ingelheim, Pfizer, Samsung Bioepis, Mylan, Sandoz and more getting involved.
Initially, Boehringer Ingelheim opted to fight AbbVie’s so-called “patent thicket” around Humira, declining a settlement and arguing in court that the company sought overlapping and add-on patents. BI also said AbbVie took advantage of the patent litigation process to delay competition. The company’s legal effort didn’t work, and BI eventually agreed to settle back in May 2019.
Now, it seems Alvotech is the only holdout for a potential biosimilar launch without going through the settlement process. The company and AbbVie have filed dueling lawsuits, with Alvotech recently suing the company over what it called a “wrongful monopoly” on the drug. Alvotech says it’s the leading biosim company seeking to market a copycat that’s equal in strength to Humira’s latest formulation.
In its lawsuit, AbbVie in March accused Alvotech of recruiting a manufacturing exec to steal Humira trade secrets.
As the industry’s top drug by sales, Humira has attracted plenty of attention over the years—and not all of it positive. In a recent report, congressional investigators said AbbVie and Abbott Laboratories upped the drug's price dozens of times over the years, raising the cost of a 40-milligram syringe to nearly $3,000.
Meanwhile, the company has faced scrutiny on the “thicket” of patents around the drug from patient advocates, lawmakers and more. The company has 257 patents on the drug, with protections running well into the next decade.
For his part, AbbVie CEO Richard Gonzalez said on an April conference call that the company’s behavior was “absolutely pro competitive.” At the time, he had been summoned to testify on Capitol Hill about the company’s Humira defense.
"We have patents all the way out to 2034 in that portfolio,” he said on the call. “And yet, we chose to license every single biosimilar player in 2023, literally 11 years before the last patent would have expired.”
The company has had years to prepare for its Humira patent cliff, and the forthcoming biosimilar competition was a driving force in the company’s decision to acquire Allergan in 2019 for $63 billion. Now, the combined drugmaker is working on growing sales for Allergan’s lucrative Botox, plus Humira’s successors Skyrizi and Rinvoq. AbbVie is hoping the latter two drugs can generate $15 billion together by 2025.
Humira generated $19.8 billion in 2020 despite copycat competition in Europe. In the U.S., the drug pulled in $16.1 billion last year.