Multinational giant AbbVie’s empire has mostly been built on its famed arthritis drug Humira, since its approval in the U.S. in 2002. But now, with a fall in revenues owing to expiring patents, AbbVie seems to be clinging on to acquisition deals to stay in the game. And with a new CEO in town, things are about to change. But will they be for the better?
News that AbbVie’s current president and chief operating officer (COO) Robert Michael would be filling the shoes of seasoned, founding chief executive officer (CEO) Richard Gonzalez in July broke out two weeks ago. The transition, which was anticipated a few months ago, follows closely on the heels of a drop in the company’s revenues by 6.4% in 2023.
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Abbvie’s Humira: a best-seller in the market
This was largely owing to biosimilars of Humira debuting in the market last year. Humira is a human monoclonal antibody prescribed to reduce pain and swelling in patients with different types of arthritis like rheumatoid, psoriatic, juvenile idiopathic, and ankylosing spondylitis. More than 53 million people in the U.S. have been diagnosed with some form of arthritis, according to the National Health Interview Survey (NHIS) that took place between 2019 and 2021.
Humira works by binding to the protein, tumor necrosis factor (TNF), and neutralizing it by blocking its interaction with receptors. Although TNF triggers inflammation as a typical response of the immune system, when in abundance, it can cause tissue damage. So, in the case of autoimmune diseases like arthritis, arresting its function can reduce inflammation.
When the drug entered the market more than two decades ago, it swiftly became one of the best-selling drugs. It even came in second after Pfizer and BioNTech’s COVID-19 vaccine Comirnaty, back in 2022. But the out-of-pocket expense of $7,299 for a carton of two pens coupled with its tight grip on its patents made it hard for people to seek more affordable alternatives to treat their arthritis. Until recently, although it has been a bumpy ride.
Humira patent expiration: catalyst for biosimilar revolution in Europe
In Europe, Humira’s patent expired in 2018, which gave way to other biotechs developing biosimilars of the drug. A biosimilar is a very similar drug to an already-approved biologic drug, which tends to be as efficacious as the original one. As they’re cheaper, they’re often sought after. But unlike generics, biosimilars are more complex and more expensive to manufacture. That’s why major drug developers like Pfizer, Boehringer Ingelheim, Mylan and Amgen, jumped on the biosimilar bandwagon since they had more money to spend compared to smaller biotechs.
So, when biosimilars premiered in the market, it ate into 35% of Humira’s sales in Europe, where biosimilars cost around 40% less than Humira at the time. This led to a slash in Humira’s prices, which was already much lower in Europe than in the U.S., with it costing less than a quarter of U.S. prices in the Netherlands and the U.K., and around a third in Germany and Switzerland. Humira biosimilars that made it to the U.K. were predicted to save the country’s National Health Service (NHS) £150 million ($191.2 million) in a year.
The Humira patent thicket detains biosimilar entry in the US
However, in the U.S., things were different. Despite Humira’s patent expiring in 2016, the drug developer continued to have a chokehold on the American market. This was primarily due to two reasons. The first one being patent thickets.
A patent thicket is a number of overlapping patents to protect a single product, in this case, Humira. In fact, AbbVie filed for a whopping 311 patents, which, according to a report by the patent tracker Initiative for Medicines, Access, and Knowledge (I-MAK), is an “egregious example of overpatenting” in the pharmaceutical industry. The pharma giant ended up padding Humira up with 165 sanctioned patents for the years to come.
Although competitors tried to put up a fight, they ended up settling to avoid a lengthy and expensive court case. American multinational company Amgen was one of the competitors who came in guns blazing with its biosimilar Amjevita to take on AbbVie back in 2017, only to settle and delay its drug’s U.S. launch to 2023.
Then, in 2021, AbbVie raised Humira’s price by nearly 10%, which the Institute for Clinical and Economic Review (ICER) argued the pharma giant was not justified in doing so. Still, the drug maker got away with this as it dominated the arthritis therapy market.
By this time, AbbVie had also formed a patent wall around its blood cancer drug Imbruvica, which works by inhibiting an enzyme called Bruton’s tyrosine kinase (Btk), thereby improving the survival of B cells in the body. The pharmaceutical had filed 165 patents for the drug, and was granted more than half of them. As a result, the drug is protected by its patents from biosimilar competition until 2036.
AbbVie’s new formulation of Humira makes delayed entry
The second reason why AbbVie was able to reign over its monopoly was by stalling the entry of a new formulation of Humira. The citrate-free, higher-concentration version of the drug, which was green lit by the U.S. Food and Drug Administration (FDA) in 2015, only hit the market in 2018, after biosimilars of the original version of Humira had been approved. As the new formulation caused much less burning and pain following an injection, this made the original version as well as its biosimilars obsolete in no time. And so, AbbVie could enjoy its monopoly for a while longer until new biosimilars caught up to it in a few years’ time.
This move drew criticism from the U.S. House Committee on Oversight and Reform, and Gonzalez was called to a congressional hearing. While AbbVie claimed that the new version required more time to manufacture, the committee rebutted by stating that there were no delays when the new version of Humira was being introduced in Europe. So, this implied that the citrate-free version, which was linked to lower side effects, was deliberately kept from patients after it had been approved, in order to stifle competition. American lawmakers like senator Bernie Sanders also called out AbbVie, among other pharma giants, for hiking drug prices, and regarding the cost disparity in the U.S. compared to European nations.
Biosimilars sweep in, makes autoimmune disease drugs affordable for many
Only last year did Amgen’s Amjevita debut in the U.S., making it the first Humira biosimilar to enter the market. And then, a swarm of biosimilars followed. Coherus BioSciences’ Yusimry was sold at an 85% discount to Humira, after it arrived in the U.S. market last year, following a resolved scuffle with AbbVie over breaching patent settlement.
Boehringer Ingelheim’s Cyltezo became the first interchangeable biosimilar to Humira to launch in the U.S., last July. An interchangeable biosimilar is one that can be substituted for its reference product – in this case, Humira – at the pharmacy without a doctor’s approval.
Other citrate-free biosimilars like Samsung Bioepis’ Hadlima and the Sandoz-owned Hyrimoz also set foot into the American drug market mid last year. Moreover, Iceland-based Alvotech overcame regulatory snags, and its biosimilar Simlandi has become the first interchangeable high-concentration, citrate-free biosimilar of Humira to score FDA clearance, this year.
After the copycat drugs took over the autoimmune disease sector, Humira’s sales dwindled by 35% last year.
Meanwhile, a public interest group in the Netherlands has taken the drugmaker to court after alleging that it was overcharging patients for Humira and breaching human rights. If the Dutch Pharmaceutical Accountability Foundation succeeds, the case could become a model for pharmaceutical companies to be held accountable for jacking up drug prices in Europe.
A new plan of action for AbbVie?
In the wake of these events, AbbVie seems headed in a different direction now. It purchased ImmunoGen for $10.1 billion, an acquisition that was completed last month. And, in an $8.7 billion deal, it will buy Cerevel Therapeutics, a biotech focused on developing drugs to treat psychiatric and neurological disorders. However, the deal with Cerevel has spurred antitrust scrutiny as the latter has Parkinson’s and schizophrenia candidates in the clinic, two fields where AbbVie already has players in the market.
The multinational pharma also seems to be raking in sales from its autoimmune disease assets, Skyrizi and Rinvoq, which made $2.39 billion and $1.26 billion respectively, in the fourth quarter of last year. Both the drugs are predicted to bring in a total of $16 billion this year, according to a report by Reuters.
Now, as Gonzalez hands over the company’s autoimmune disease assets, Skyrizi and Rinvoq, to potentially chase and replace the Humira stardom, over to Michael, how the succession will play out, only time will tell.