House Committee Takes on Pricing, Patents for Top-Selling Drug Humira
By Jared S. Hopkins
AbbVie Inc.'s pricing practices for some of its top-selling
medicines are expected to face fresh scrutiny from federal
lawmakers Tuesday, the latest effort by members of Congress probing
the cost of prescription drugs.
Democratic members of the U.S. House Committee on Oversight and
Reform have been investigating how AbbVie sets the prices of some
of its products, including its top-selling immunology drug,
At a hearing, the committee is scheduled to question AbbVie
Chief Executive Richard Gonzalez.
He is expected to face questions about price increases for
Humira as well as AbbVie's patents and other efforts to protect the
drug from competition from lower-priced copies known as
The company "seeks to overwhelm potential competitors with the
sheer number of patents on Humira regardless of whether individual
patents were properly granted under U.S. law," committee Democrats
wrote in a report released before the hearing. "If one patent is
invalidated, AbbVie has another patent waiting."
AbbVie declined to comment, a spokesman said.
Republican members of the committee don't plan to issue a report
related to the hearing before its start, a spokeswoman for them
Patents on Covid-19 vaccines have emerged as an issue in the
coronavirus pandemic, as some governments push for intellectual
property rights to be temporarily waived to spur additional
The Biden administration recently lent its support for
temporarily waiving the vaccine patents.
Humira, which treats a range of immune conditions including
rheumatoid arthritis and gut disorders, is the top-selling drug in
the U.S. with more than $16.1 billion in sales last year.
AbbVie has raised Humira's price 27 times since it launched in
2003, with a year's supply now costing $77,586 before insurance and
rebates, according to the report by committee Democrats.
Humira's current price is 470% higher than from when the drug
launched in 2003, according to the report.
The initial U.S. patent for Humira expired in December 2016, but
the company has been taking out additional patents covering its
formulation and manufacturing, among other things.
AbbVie executives in 2014 forecast Humira biosimilars would
arrive in the U.S. in 2017 and decrease sales by $1.5 billion that
year, according to the report, citing company documents.
The drugmaker, based in the suburbs of Chicago, has obtained or
applied for at least 257 Humira patents, 90% of which were filed
after the drug was launched, according to the report.
The company obtained eight patents under a law designed by
Congress to encourage development of drugs for rare diseases
affecting fewer than 200,000 people in the U.S., according to the
In one instance, AbbVie split the patient population of a rare
skin condition into two, a general one and one for patients at
least 12 years old. The maneuvers extended Humira's patent
protection beyond the seven years intended by the federal
orphan-drug law, according to the report.
AbbVie viewed the U.S. patent system as more permissive than
other countries' intellectual-property systems, the Democrats on
the committee said, citing company documents.
Europe's patent system precluded many patents obtained in the
U.S., according to one of the company documents, an AbbVie white
paper, that the committee Democrats cited. In Europe, several
biosimilars to Humira have been available since 2018 at a reduced
The first lower-priced alternatives to Humira, known as
biosimilars, aren't scheduled to hit the U.S. market until
AbbVie staved off biosimilar competition by reaching deals with
companies that agreed to delay launches of their lower-priced
copies, according to the report and the companies.
Some of these biosimilars have been approved for several years.
A biosimilar from Amgen Inc., which is scheduled to launch in 2023
under an agreement with AbbVie, was approved by regulators in
Write to Jared S. Hopkins at firstname.lastname@example.org
(END) Dow Jones Newswires
May 18, 2021 10:03 ET (14:03 GMT)
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