Chairs Maloney, Nadler, and Cicilline Ask FTC to Open Formal Inquiry into AbbVie

May 18, 2021
Press Release
Documents Show Company Delayed U.S. Biosimilar Entry for Blockbuster Drug Humira

Washington, D.C. (May 18, 2021)— Today, Rep. Carolyn B. Maloney, Chairwoman of the Committee on Oversight and Reform, Rep. Jerrold Nadler, Chairman of the Committee on the Judiciary, and Rep. David N. Cicilline, Chairman of the Committee on the Judiciary’s Subcommittee on Antitrust, Commercial, and Administrative Law, sent a letter to Federal Trade Commission (FTC) Acting Chair Rebecca Kelly Slaughter requesting a formal inquiry into AbbVie Inc.’s actions to delay U.S. biosimilar entry for its blockbuster drug Humira.

 

“We make this request in light of previously non-public documents obtained by the Committee on Oversight and Reform during its multi-year investigation of AbbVie,” the Members wrote.  “Based on our review, these documents indicate that AbbVie delayed biosimilar competition for far longer than warranted by its own internal evaluations of the strength of its patent portfolio, which anticipated biosimilar entry no later than 2017.  We ask that you investigate whether this delay was the result of anticompetitive conduct in violation of U.S. law.”

 

Earlier today, Chairwoman Maloney released a staff report and accompanying documents based on the review of more than 170,000 pages of AbbVie’s internal documents, communications, and data related to Humira and Imbruvica from 2009 to the present. 

 

AbbVie is the sole U.S. manufacturer of Humira, an injectable biologic agent approved to treat inflammatory diseases such as rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, and Crohn’s disease.  AbbVie charges approximately $77,000 for a year’s supply of Humira—470% more than when the drug was launched in 2003.  In part due to AbbVie’s price increases, Humira is the highest-grossing drug in the United States.  In 2020 alone, AbbVie collected $16 billion in U.S. net revenue for Humira. 

 

AbbVie faces no current competition in the United States from lower-priced biosimilar versions of Humira, even though six biosimilars have received marketing approval from the Food and Drug Administration. 

 

“As the FTC is aware, AbbVie has entered into nine patent settlement agreements with potential biosimilar competitors,” the Members wrote.  “Under the terms of these agreements, Amgen will not introduce its biosimilar until January 31, 2023, and other biosimilars will enter later that year.  In contrast, AbbVie already faces competition in Europe from at least six biosimilars, and the price of the drug has fallen by as much as 80% since competition first entered the market.”

 

The Members also asked the FTC to examine whether AbbVie engaged in other anticompetitive conduct to maintain its market share and pricing power for Humira, such as shifting patients to a higher concentration formulation of the drug and using bundled rebates to exclude rivals of preferred formulary positions.

 

Today, the Committee on Oversight and Reform is holding a hybrid hearing with AbbVie CEO, Richard Gonzalez, and experts on pricing practices for Humira and Imbruvica that can be viewed on the Committee’s website and YouTube.

 

Click here to read today’s letter to the Federal Trade Commission.

 

Background:

 

On April 29, 2021, the Committee on the Judiciary’s Subcommittee on Antitrust, Commercial, and Administrative Law held a hearing entitled, “Treating the Problem:  Addressing Anticompetitive Conduct and Consolidation in Health Care Markets.” Chairwoman Maloney testified during that hearing.

 

The same day, Chairs Maloney, Nadler, and Cicilline joined a bipartisan, bicameral group of Members and Senators to introduce legislation that would target anticompetitive practices by large drug companies. 

 

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117th Congress