For two decades AbbVie has aggressively protected its exclusive right to sell the anti-inflammatory drug Humira in the US, enabling it to ratchet up prices and amass an eye-watering $200bn in total sales since the medicine was launched.
But from Tuesday, the world’s best-selling drug will face competition for the first time in the US when Amgen launches a copycat version in a move that could halve the cost for insurers, employers and the government while also reducing prices for patients.
Amgen said it would offer its biologic treatment, named Amjevita, to US health insurers and middlemen known as pharmacy benefit managers through two pricing plans. These would provide its drug at a discount of either 55 per cent or 5 per cent compared with Humira’s current list price, which is $6,922.62 for a four-week course.
“All patients will have some benefit. Some patients will benefit more . . . it will depend on their insurance,” said Murdo Gordon, Amgen’s vice-president of global commercial operations.
Amgen is offering two pricing plans because in the complex US healthcare system — where the real cost of a drug tends to be the decided via opaque deals — some pharmacy benefit managers prefer higher list prices because it allows them to negotiate larger rebates from manufacturers.
Amjevita is a so-called biosimilar product, which means it is almost identical to the original monoclonal antibody manufactured by AbbVie. It can be prescribed to treat seven inflammatory conditions, including arthritis, psoriasis and Crohn’s disease.
It is the first of up to eight biosimilar drugs expected to launch this year in the US to compete with Humira, a drug that generated $15.7bn of sales in the first nine months of last year, or about 37 per cent of AbbVie’s total revenue.
Amjevita was first approved by US regulators in 2016 but its launch in the country has not been possible because of AbbVie’s use of a controversial intellectual property strategy known as a “patent thicket”, which involves applying for multiple patents in addition to the original one.
The original US patent covering the composition of Humira expired in 2016 but AbbVie has obtained more than 150 other patents related to the drug, a strategy that experts say is an effective way to prevent competitors from entering the market. The first wave of Humira biosimilars were launched in Europe in 2018.
“Humira is the most valuable biologic drug ever and AbbVie is known as one of the most aggressive pharma companies ever. So, of course it created the densest patent thicket ever,” said Brian O’Reilly, the founding partner of the law firm O’Reilly IP.
He said such aggressive patent strategies provide strong financial returns for pharma companies and had become standard practice in the industry. Merck, Bristol Myers Squibb and Amgen have all used these aggressive tactics to protect blockbuster drugs from competition, said O’Reilly.
Last year a US appeals court ruled that AbbVie’s use of a patent thicket did not unlawfully block competition. But critics allege the strategy is pushing up healthcare costs while short-changing patients. They are lobbying the Biden administration to take action.
David Mitchell, a cancer patient and founder of Patients For Affordable Drugs, said Humira was the “poster child” for misusing the patents system.
“The result is that we have been paying roughly five times what they pay in the EU for Humira. And patients in the US have suffered economic and physical harm as a result,” he said.