- AbbVie tried to tout large revenue gains for lymphoma drug Imbruvica and give a positive outlook on its late-stage oncology antibody Rova-T (rovalpituzumab tesirine) during its fourth quarter earnings call, but investors were more interested in the future facing Humira (adalimumab).
- The Chicago-based drugmaker has devoted much time in the past to easing worries that biosimilars could snatch revenues from the megahit anti-inflammatory treatment. That trend continued Friday.
- Humira raked in nearly $4.3 billion during the fourth quarter, with U.S. sales up 23.5% to $2.9 billion. AbbVie expects U.S. sales of the drug to grow in the mid- to high-teens in 2017.
Same story, different quarter.
For AbbVie, the strength of Humira has been a double-edged sword. The drug was responsible for more than 63% of net revenue during the quarter, which isn't uncommon for the company. And while AbbVie was able to achieve its goal of U.S. Humira sales increasing by at least 20% during the fourth quarter, the feat also reinforces the idea that the company is too reliant on the blockbuster drug.
Not helping the company's position is the looming pressure of biosimilar competition. The Food and Drug Administration has already approved Amgen's Amjevita (adalimumab-atto). So far, AbbVie has benefited from keeping Amgen's biosimilar at bay through ongoing patent litigation that shouldn't let up — at least not until next year — as well as a regulatory hiccup for potential competitor Coherus. But with several other Humira biosimilars in development, the threat is clear.
During the Jan. 27 call, the company attempted to address the how biosimilars, as well as the Food and Drug Administration's recent interchangeability guidance, could affect Humira.
"We don't believe based on what we know that any of the single switch studies that are being done now would meet [the FDA's standard]," AbbVie CEO Richard Gonzalez said during the call. "But we'll have to see how the competitive dynamics play out as people look at this and start to design programs in order to try to achieve interchangeability. I think we'll have to see how that plays out over time."
In other news, AbbVie gave updates on some of its more anticipated pipeline candidates and M&A. The company expects data from a Phase 2 study for its Rova-T drug (which it gained through an acquisition of Stemcentrx worth up to $10 billion) later this year and to file it for approval with the Food and Drug Administration soon after.
As for deals, the company as expected said it didn't have any on tap, but that it is more interested in asset acquisitions — for now anyway.
Note: A previous version of this article referred incorrectly to Pfizer and Celltrion's biosimilar Inflectra as a competitive threat to AbbVie's Humira. Inflectra is a biosimilar of Remicade, not Humira.