House committee to grill AbbVie CEO next month on suppressing Humira competition
AbbVie CEO Richard Gonzalez will be in the hot seat on May 18, again defending the company’s mammoth blockbuster drug Humira before the House Oversight Committee as competition for the world’s best-selling drug isn’t likely to hit American shores for about two years.
Oversight Committee Chairwoman Carolyn Maloney (D-NY) has been zeroing in on AbbVie for months now, even threatening to issue a subpoena last September for documents as part of her committee’s ongoing investigation into drug pricing practices.
And with good reason. AbbVie’s cash cow Humira, which has brought in more than $90 billion over the last five years, already faces biosimilar competition in the EU, but will not face such competition in the US until 2023.
In results from the most recent quarter reported on Friday, AbbVie noted an almost 7% increase in net revenues for Humira, despite a more than 8% decline in revenues internationally.
Six Humira biosimilars in the EU have made their mark, capturing more than 50% market share in about two years, according to a March report from Bernstein biotech analyst Ronny Gal. The price for Humira in the EU has also dropped by more than 50% over that same time period, according to Gal.
What remains to be seen is what this latest committee investigation will actually do. Gonzalez previously testified in 2019 before the Senate Finance Committee, noting, “We think we have struck a reasonable balance” on Humira with the 2023 launch dates for biosimilars, and saying the patent thickets to protect the company’s monopoly were justified. “Well, remember Humira is like nine different drugs, 10 different drugs,” he said.
Maloney testified before a different House subcommittee on Thursday, noting that her committee now has previously nonpublic internal documents that show how AbbVie’s tactics suppressed competition for Humira and other drugs and maintained monopoly pricing in the US.
But experts who spoke anonymously with Endpoints News didn’t think there was a good chance that anything would change before 2023, unless the Federal Trade Commission took on AbbVie or if AbbVie executives were indicted.
Separately, Boehringer Ingelheim, one of the companies expecting to bring a Humira biosimilar to market in 2023, held a meeting last month to discuss a citizen petition that raises concerns with the FDA about its interpretation of the biosimilars law with regard to interchangeable biosimilars.
Boehringer is one of the few companies to publicly disclose that it’s working on an interchangeable biosimilar for Humira.
“BI maintained that FDA’s current interpretation of the statutory term ‘strength’ provides an opportunity for reference product application holders to game the system through ‘product-hopping,’ which BI described as converting patients to a new concentration of the branded product and withdrawing the existing concentration prior to the entry of competing biosimilars,” according to a summary of the meeting.
The company also said that FDA’s interpretation of “strength” facilitates anticompetitive evergreening tactics, and asserted that such types of evergreening tactics would not be possible if strength is interpreted in the law to mean total drug content without regard to concentration.