Humira: AbbVie’s Innovative Medicine and Its Impact
Sales of AbbVie’s blockbuster drug Humira peaked at $18.9 billion last year, and the product is expected to generate $15.2 billion by 2024, according to analysts at Evaluate Pharma. While these figures indicate the drug’s continued dominance in the global market, Humira’s success story is not without challenges.
Barbara Gilmore, senior industry analyst at Frost & Sullivan, looks back on its development. “Humira (D2E7, adalimumab) was originally developed through a joint venture between the UK’s Cambridge Antibody Technologies and BASF,” she explains. “In 2000, Abbott acquired the pharmaceutical division of German chemical company BASF for $6.9 billion. At the time, Abbott was being heavily criticized by many investment banks for not having a blockbuster drug in its pipeline. Abbott was hopeful that D2E7 would be the blockbuster they needed.”
Abbott was split into two companies in 2013, and the pharmaceutical company acquired the name AbbVie. Humira was transferred to AbbVie, where it remains today.
Humira: Developing a blockbuster
Lifelong chronic diseases that require ongoing treatment and diseases with high prevalence are big revenue streams for drugs such as Humira. Life cycle planning has been a key factor in the success of this drug, which has been approved for nine different indications, including rheumatoid arthritis (2003), psoriatic arthritis (2005) and Crohn’s disease in adults (2007).
“AbbVie’s investments in lifecycle management and clinical trials across multiple indications have been critical to the success of this medicine.”
“When a drug’s price is high initially and then incrementally increased twice each year, revenues soar,” Gilmore continues. “AbbVie’s investments in lifecycle management and clinical trials for multiple indications have been critical to the drug’s success.”
Lifecycle planning also includes the development of new formulations and routes of administration, which could extend the patent lifespan by several years. In 2006, AbbVie launched an autoinjection device, the Humira Pen, which is currently in Phase 3 clinical trials for three additional indications: unspecified arthritis, peripheral spondyloarthritis, and pyoderma gangrenosum.
“When a new indication is approved for a disease with a low patient population (a ‘orphan’ indication with fewer than 200,000 patients), the orphan drug can receive an additional seven years of exclusivity for that specific rare disease indication, even if exclusivity for other indications is lost,” Gilmore explains.
Adopting Humira’s streamlined marketing strategy has also been beneficial for AbbVie. “When we think about our marketing efforts for these indications, we realize that we only need to approach a few physician specialties, which means that it’s cost-effective when it comes to the specifics,” says Gilmore. “If one rheumatologist can prescribe the drug for more than half of the indications and a gastroenterologist can prescribe for a few other indications, our sales reps can cover a larger geography while making fewer calls to physicians.”
Patent Expirations and Biosimilars: Opening the Door to Competition
Humira’s original U.S. patent expired in December 2016, but AbbVie has used its patent portfolio and new patents on the drug’s manufacturing and formulation to secure several more years of exclusivity.
“In Europe, the expiry of patents on the biologics Enbrel and Remicade has resulted in a 10-15% drop in treatment costs, and we will likely see a similar trend with Humira.”
“The European patent expires in October 2018, paving the way for biosimilars in the European market,” Gilmore says. “In the U.S., patent exclusivity expires on January 21, 2023, so Amgen (Abjevita) and Samsung Bioepis (Imraldi) Humira biosimilars will not be available on the market until then. In Europe, when the patents of the biologics Enbrel and Remicade expired, treatment costs fell by 10-15%, and Humira will likely follow the same trend.”
While doctors have expressed concerns about the safety of biosimilars, Amgen is respected in the industry for its manufacturing “know-how” in both oncology and immunology, which could increase doctors’ confidence in prescribing a Humira biosimilar.
AbbVie employed a technique with Humira known in the industry as “delayed compensation.” “This has been used in the past for patent expirations of small molecule drugs, but not often for biologics,” Gilmore notes. “A delayed compensation approach is when a company with a key patent that is gradually expiring pays a competitor to postpone sales of its product in the U.S. until a certain date. This is what AbbVie did with both Amgen and Samsung Bioepis. This cost AbbVie a lot of revenue, but it gave them a concrete date to project into their future.”
Challenges and criticisms: Patients pay a high price amid skyrocketing costs
In 2017, AbbVie was heavily criticized by the U.S. Food and Drug Administration for its mishandling of death complaints related to its drugs Humira and Venclexta. (The company declined to comment for this story.)
“AbbVie is focused on developing a stronger pipeline across more areas to address the biosimilar erosion that Humira is expected to eventually experience.”
AbbVie has also been criticized for steep price hikes, and it is not unusual for pharmaceutical companies to raise drug prices every six months. Typically, AbbVie has raised the price of Humira by an average of 7 to 10 percent every January and June, Gilmore said. “The price increase is undoubtedly a burden for both patients and insurers, as the drug was already expensive to begin with. With limited patient assistance programs in the U.S., compliance has reportedly decreased as patients don’t take what they can’t afford. However, because Phase 3 clinical trials are extremely expensive, there is some justification for a price increase for Humira in many respects, including the evolution of the life cycle and the addition of additional indications.”
In the U.S., Medicare spending on Humira tripled, or increased 224%, from 2011 to 2015, reflecting a 79% increase in unit costs, according to Gilmore.
“High-cost drugs are coming under increased scrutiny from government payers and insurers, and AbbVie is not alone in criticism,” Gilmore continues. “It was Gilead’s Hepatitis C drug that caused uproar in 2017, but now delays have made Humira so expensive that it’s a concern. And from a patient perspective, compliance will be an issue.”
Gilmore believes the price of the drug will fall in the European Union from October 2018, when a biosimilar becomes available. “At least some parts of the world will be able to continue using the drug with reduced costs. The US does not have a reference price like Europe and Japan. In other parts of the world, initial prices are set by the government. In Japan, companies are required to lower prices every two years.”
The Future of Humira and AbbVie
AbbVie is expanding its immunology pipeline from a single product (Humira) to a diverse portfolio of drugs.
“The company has a strong pipeline, a solid strategic plan, and sufficient revenue to conduct clinical trials and make the changes required by the FDA. AbbVie will focus on developing a stronger pipeline in more areas to manage the biosimilar erosion that Humira is expected to eventually experience,” Gilmore concluded.
“Humira: The Rise and Fall of the World’s Best-Selling Drug” was originally published by Pharmaceutical Technologya brand owned by GlobalData.
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