"AbbVie Inc.'s arthritis therapy Humira is set to face its first competition in the U.S. from a nearly identical copycat, the end of the exclusive run of what was for years the country's biggest-selling drug.
After two decades of patent protection and more than $135 billion in U.S. sales, Humira has begun contending with a version from Amgen Inc. as of Tuesday, Amgen said. Other Humira copycats are due to become available later this year.
AbbVie had fought for years to protect Humira and its sales from copycats. Under settlements with the various competitors, AbbVie can't hold off nearly identical rivals any longer. Its aggressive defense should help it hold on to most sales for several months, but Humira's dominance is expected to start cracking by later this year when other copycats go on sale.
The competition should eventually drive down prices and save health insurers billions of dollars a year while sending AbbVie searching for new sources of sales, analysts said.
Employers and health plans have been looking forward to the arrival of Humira copycats, known as biosimilars, because AbbVie's drug usually is among their top three drug costs, according to analysts and consultants. A year's supply now lists for about $90,000.
Older biosimilars have reduced drug costs of health plans by 20% to 30% a prescription, said Katie Asch, the U.S. pharmacy leader at Willis Towers Watson PLC, which advises employers on pharmacy benefits.
Amgen is taking the unusual step of offering its new biosimilar, Amjevita, at two prices: about $40,500 for a year's supply, a 55% discount to the list price of Humira; and a version that would list for 5% less at $85,494. The prices are before insurance and other discounts.
Amjevita is unlikely to cause a major decline in Humira use immediately because AbbVie has said that it has reduced its price in contracts to maintain volume, analysts said.
AbbVie has projected that Humira U.S. sales may drop by roughly 45% during the course of the year. SVB Securities analysts recently raised its forecast for the amount of sales AbbVie could retain, partly because health plans will keep covering the drug.
Humira, which is cleared to treat rheumatoid arthritis, psoriasis and other autoimmune diseases, first earned approval from the U.S. Food and Drug Administration in 2002.
The drug held the title of the top-selling pharmaceutical for years until Covid-19 vaccines took the mantle. In 2021, Humira generated roughly $21 billion in sales worldwide, including $17 billion in the U.S. On Feb. 9, AbbVie is scheduled to report full-year sales for 2022.
The drug accounts for about one-third of AbbVie's sales.
Humira is known as a biotech drug, or biologic, because it is made from living cells in a process that resembles brewing.
For years, biotech drugs, which are largely injected or infused, didn't face competition even after their patents expired, like pills did with generics. Companies seeking to introduce a rival product would have to test it and get it approved as if it were an entirely new drug.
In the 2010 Affordable Care Act, Congress established a process for rival companies to sell biosimilars based largely on existing knowledge about the safety and effectiveness of the original drug. The originals got 12 years of protection from competition in exchange.
The FDA has approved 40 biosimilars, but their use has been less than expected because drugmakers like AbbVie have taken out additional patents and kept contracts with drug-benefit managers by offering volume-based discounts.
The main U.S. patent related to Humira expired in 2016, but AbbVie obtained more than 100 additional U.S. patents. AbbVie cited those patents, which the company said extended into the 2020s and 2030s, in litigation seeking to protect Humira from biosimilar competition. Critics say AbbVie abused the U.S. patent system to preserve sales.
The legal strategy prevented the developers of biosimilar versions from launching their products in the U.S., even after the FDA had approved them and while some copycats began selling in Europe in 2018.
The FDA approved Amjevita in 2016, but its launch was held up as Amgen and AbbVie were tied up in litigation. The companies resolved their legal dispute in an agreement that paved the way for Tuesday's Amjevita launch.
Under other settlements, at least eight additional FDA-approved Humira biosimilars are due to launch this year.
Amjevita could generate roughly $1 billion in sales this year given its advantage as the first Humira biosimilar, according to Cowen & Co." [1]
1. Business News: Blockbuster Drug Faces First U.S. Copycat
Hopkins, Jared S. Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 01 Feb 2023: B.6.
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