Pricing and Affordability Concerns
From its launch in 2003 until 2023, AbbVie repeatedly raised the price of Humira, a blockbuster drug for autoimmune diseases. A congressional investigation found the list price increased significantly, reaching approximately $77,000 annually for a typical year's supply. These price hikes contributed to substantial profits for AbbVie but resulted in high out-of-pocket costs for patients.
Critics argued the aggressive pricing wasn't justified by manufacturing costs or innovation. Class-action lawsuits alleged AbbVie inflated the drug's price. The high cost made treatment unaffordable for many, forcing difficult health decisions.
The 'Patent Thicket' and Blocked Competition
While Humira's core patent expired in 2016, AbbVie delayed biosimilar alternatives from entering the US market for years using a "patent thicket" strategy. This involved filing hundreds of additional patents related to manufacturing and formulations. Many biosimilar manufacturers settled with AbbVie, delaying US market entry until 2023, despite biosimilars being available in Europe since 2018 at lower prices.
Antitrust lawsuits challenged this strategy, but courts favored AbbVie, citing the Noerr-Pennington doctrine. The delayed entry of biosimilars is seen as an example of how pharmaceutical companies can use the patent system to maintain monopolies and high prices.
Controversial Marketing and Kickbacks
AbbVie faced allegations of using illegal kickbacks to boost Humira prescriptions. California sued in 2018, alleging AbbVie provided incentives like cash and gifts to physicians. The complaint also described a program using nurse "Ambassadors" who allegedly downplayed side effect risks. A 2020 settlement included a monetary payment and marketing practice reforms.
Patient Safety and Failure-to-Warn Lawsuits
The controversy also includes patient lawsuits alleging AbbVie and its predecessor, Abbott, failed to provide adequate warnings about serious side effects. Lawsuits raised issues related to:
- Serious Infections: The risk of severe infections, including tuberculosis and fungal infections, is mentioned in Humira's boxed warning. Some lawsuits claimed delayed warnings despite early FDA alerts.
- Cancer Risks: Concerns about increased cancer risk, particularly lymphoma, were raised, with specific cases of hepatosplenic T-cell lymphoma (HSTCL) reported in certain patients.
- Neurological Damage: Early lawsuits alleged Humira caused nerve damage and that warnings were insufficient.
The Slow March of Competition
With biosimilar competition arriving in the US market in 2023, the situation is changing, though the impact of AbbVie's prolonged monopoly remains a key part of the Humira controversy. The effect on pricing and patient access is still unfolding.
Here is a comparison of branded Humira's history versus the delayed biosimilar launch:
| Feature | Branded Humira (AbbVie) | Humira Biosimilars (e.g., Amjevita, Hyrimoz) |
|---|---|---|
| US Market Entry | 2003 | 2023 |
| Core Patent Expiration | 2016 | N/A |
| Patent Tactics | Extensive "patent thicket" to delay competition | Faced litigation and settlement agreements with AbbVie |
| Pricing Strategy | Numerous, significant price increases | Generally offered at a significant discount to Humira's list price |
| US Competition | Maintained monopoly for years post-core patent expiry | Launched with delayed entry due to AbbVie's legal tactics |
| EU Competition | Faced competition much earlier, starting in 2018 | Entered European market much earlier than US |
Conclusion
The Humira controversy highlights the tension between patient needs and pharmaceutical company profits. AbbVie's patent system manipulation and pricing tactics enabled a prolonged monopoly. While biosimilars are now available, the Humira story has influenced public perception and the debate over drug pricing. The multi-layered issues underscore the challenges in controlling healthcare costs and promoting fair competition in the pharmaceutical industry. For more information, see The New York Times article "How a Drug Company Made $114 Billion by Gaming the U.S. Patent System".
