AbbVie
Humira's patent thicket, 27 price increases, nurse "ambassadors" and product hopping
AbbVie, spun out of Abbott Laboratories in 2013, built its business on Humira (adalimumab), for years the world's best-selling drug. A House investigation concluded AbbVie exploited the patent system and raised Humira's price 27 times; biosimilars arrived in Europe in 2018 but not in the US until 2023. AbbVie has also settled allegations that it used nurse "ambassadors" and gifts to drive Humira prescriptions.
Questions
Why is AbbVie considered a controversial drugmaker?
A House investigation concluded AbbVie exploited the patent system to extend Humira's US monopoly four years longer than in Europe, raised its price 27 times, and engaged in shadow pricing with its closest competitor.
AbbVie has become the leading example of how a company can extend a drug's US monopoly long after its core patent expires. A 2021 House Oversight Committee report, built on 170,000 pages of internal documents obtained under subpoena threat, concluded that AbbVie exploited the patent system and engaged in anticompetitive practices to extend its monopoly pricing. The report documented 27 price increases for Humira and found US patients paid far more than those in other countries.
Q2How much did Humira's price rise?
AbbVie raised Humira's price 27 times since 2003, reaching $77,586 per year by 2021 — a 470% increase from launch — while net price, after rebates, rose 110% from 2009 to 2018.
According to the House Oversight Committee, AbbVie and its predecessor raised Humira's price 27 times since launch in 2003, including by nearly 30% in one 10-month period. A 40mg syringe cost $2,984 by 2021, or $77,586 a year, a 470% increase from launch. The committee found that list price increases far outpaced rebates: Humira's net price, after discounts and rebates, rose 110% between 2009 and 2018, from $16,663 to $35,041 a year.
Q3What is the Humira "patent thicket"?
AbbVie filed 250 patents on Humira — about 90% after the drug was approved — with protection claimed until 2037, then used litigation threats to keep US biosimilars out until 2023, four years after European competitors launched.
The core patent on adalimumab expired in the US in 2016, but AbbVie had built a dense web of secondary patents on manufacturing, formulations and uses. The House report found AbbVie filed 250 patents on Humira, about 90% of them after the drug was approved, with protection claimed until 2037. Internal documents showed that by 2014 executives had expected three to five biosimilar competitors by 2017.
Q4How did Humira's pricing in the US compare with Europe?
Once biosimilars launched in Europe in October 2018, AbbVie cut Humira's price there by up to 80% — while maintaining high US prices and settling with biosimilar makers to delay US entry until 2023, more than four years after European competition began.
The difference became stark once biosimilars launched in Europe in October 2018. AbbVie responded by cutting Humira's price by as much as 80% in Europe, while saying it was not losing money at that level. In the US, AbbVie had settled patent litigation with eight biosimilar makers, all agreeing to US entry dates in 2023, more than four years after European competition began.
Q5What was the "shadow pricing" finding?
The House report found AbbVie and Amgen raised their prices in near-lockstep through dozens of increases from 2003 to 2021 — not undercutting each other to gain market share, but mirroring each other's prices almost exactly.
The House report found that Humira's closest competitor, Amgen's Enbrel, did not act as a price constraint. Instead of undercutting each other to gain market share, AbbVie and Amgen engaged in shadow pricing, consistently following each other's price increases, with their prices mirroring each other almost exactly through dozens of increases from 2003 to 2021.
Q6What were the nurse "ambassador" allegations?
AbbVie paid $24 million in 2020 to settle allegations that it deployed nurses to reinforce Humira prescriptions while also offering doctors cash, meals, trips and patient referrals — blurring the line between patient support and commercial promotion.
In 2018 California's insurance commissioner joined a whistleblower lawsuit alleging that AbbVie used illegal kickbacks to promote Humira. In August 2020 AbbVie agreed to pay $24 million to settle. The case alleged that AbbVie deployed nurses, sometimes by phone and sometimes in patients' homes, to help ensure prescriptions were refilled, blurring the line between caregiver and marketer, and that doctors were offered cash, meals, drinks, gifts, trips and patient referrals.
Q7What is the product-hopping criticism of AbbVie?
As biosimilars arrived, critics say AbbVie offered Humira patients coupons for newer patent-protected Skyrizi and Rinvoq — allowing it to retain immunology revenue even as biosimilars captured Humira's share, with payers eventually bearing the higher cost once coupons expire.
As biosimilars approached, critics say AbbVie worked to move patients to newer, patent-protected drugs in the same therapeutic area, particularly Skyrizi and Rinvoq. One pharmacy-cost firm described the tactic as offering patients on Humira a coupon for Skyrizi just as biosimilars launched, and said it allowed AbbVie to preserve a substantial share of the immunology market despite ten biosimilars.
Q8Did AbbVie's tax arrangements draw criticism too?
A Senate Finance Committee report found US Humira intellectual property rights were held through a Bermuda subsidiary despite more than 77% of AbbVie's worldwide sales being made in the United States — a lawful structure that allowed profits to be booked in low-tax jurisdictions.
Yes. A Senate Finance Committee staff report on pharmaceutical tax avoidance found that the intellectual property rights for US Humira sales were held by a subsidiary incorporated in Bermuda, operating through a branch in Puerto Rico, even though more than 77% of AbbVie's worldwide sales were made in the United States. The report argued such structures allowed profits from American patients to be booked in low-tax jurisdictions.
Q9What did the House investigation find about Imbruvica?
AbbVie and Janssen raised Imbruvica's price nine times since its 2013 launch, to $181,529 per year — an 82% increase — with the House report saying AbbVie pursued patent strategies and orphan-drug protections to block competition.
The House Oversight Committee's investigation also covered AbbVie's cancer drug Imbruvica (ibrutinib), sold with Janssen. The committee found AbbVie and Janssen had raised Imbruvica's price nine times since its 2013 launch, so that by 2021 it cost $181,529 a year for a patient taking three pills a day, compared with $99,776 at launch, an 82% increase.
Q10How did biosimilar entry finally change Humira's position?
Slowly at first, then abruptly — after CVS Caremark removed Humira from major formularies on April 1, 2024, biosimilar share at CVS reached about 22% by October 2024, with all three big PBMs shifting to private-label biosimilars for 2025.
Slowly at first, then abruptly. After biosimilars launched in 2023, their share stayed around 2% to 3% because PBM formularies largely kept branded Humira. That changed on April 1, 2024, when CVS Caremark removed Humira from its major national commercial formularies, preferring biosimilars including its own Cordavis private label. By October 2024 biosimilar share at CVS had reached about 22%.
Q11What is the overall significance of the AbbVie controversies?
Humira's strategy is now the template critics cite for patent reform — one proposal would have reduced AbbVie's assertable patents from 105 to 24 — and the case for limiting how many patents can block biosimilars has found bipartisan support in Congress.
AbbVie's Humira strategy is now the template critics cite when calling for patent reform, and its effects on the biosimilar market are still playing out. Proposals in Congress would limit how many patents can be asserted against biosimilars: one would have reduced AbbVie's assertable Humira patents from 105 to 24.