AbbVie’s Humira Is a Textbook Case for Drugmakers Navigating Patent Cliff

Pictured: AbbVie's office in South San Francisco, California

Pictured: AbbVie’s office in South San Francisco, California

iStock, vzphotos

Thanks to the success of outgoing CEO Richard Gonzalez, biopharma executives will be studying for years to come how AbbVie navigated the decline of blockbuster Humira.

Pictured: Glass building with AbbVie sign/iStock, vzphotos

This week’s news that AbbVie CEO Richard Gonzalez will retire in July after 11 years at the helm is essentially him declaring victory. Despite the U.S. patent cliff for its blockbuster anti-inflammatory drug Humira, the biopharma has for years been able to successfully withstand competition from low-cost biosimilars.

If you’re straining to see the connection between Gonzalez’s retirement and Humira’s loss of exclusivity (LOE), listen to AbbVie’s investor call earlier this month on its fourth quarter and full-year 2023 results, which laid out the criteria for Gonzalez stepping down as CEO. Asked about succession planning by an analyst on the call, Gonzalez said: “When we believe that we are comfortable, we’ve navigated the LOE, and the rest of the business is performing at high level, that’s the point at which we want to make the transition.”

Gonzalez also said that for over a decade he has been focused on developing a strategy that would allow AbbVie “to be able to offset the Humira LOE and continue to deliver top-tier financial performance . . . that was the whole objective.” Mission accomplished: Humira is now a textbook example of how biopharma companies can effectively use legal strategies to delay biosimilar competition.

While Humira peaked at $21 billion in annual sales in 2022 and is expected drop to about $4 billion by 2028, the biosimilars that first became available in the U.S. last year have largely been unable to shake AbbVie’s tight grip on the market—despite some of these alternatives having discounts of around 85% compared to the branded product. In fact, Humira has ceded only 2% of its market share to the five biosimilars that entered the U.S. market in 2023, according to a report last month from Samsung Bioepis.

Say what you will about AbbVie’s “thicket” of overlapping patents that for years extended Humira’s monopoly and delayed the entry of low-cost biosimilars in the U.S. The AbbVie business model may have ripped off patients in this country, forcing them to pay inflated prices for their prescriptions, but it made Humira into one of the highest-grossing drugs of all time by preserving the company’s pricing power and bringing in more than $200 billion in revenue during its lifetime. And Gonzalez deserves the credit—or the blame, depending on your point of view—for this major coup.

At the same time, other drugmakers have successfully implemented similar strategies for some of their top-selling drugs, including Bristol Myers Squibb’s Eliquis, Johnson & Johnson’s Stelara and Merck’s Keytruda—all of which are set to lose exclusivity over the next few years. Earlier this month, the Senate health committee released a report concluding that BMS, J&J and Merck have built patent thickets allowing them to “artificially extend their monopolies” while making “it harder for Americans to access lower-cost generics and biosimilars.”

According to the report, Merck has filed 168 patents on its blockbuster Keytruda—64% of which were filed after the immunotherapy first received the FDA’s greenlight—while 57 patents have been filed on J&J’s immunosuppressive drug Stelara, 79% of which were filed post-approval. Meanwhile, BMS has filed 37 patents on Eliquis, nearly a third of which came after FDA approval.

By comparison, AbbVie obtained or applied for 250 patents for Humira, according to a December 2021 report by the House Committee on Oversight and Reform. Many of these patents covered AbbVie’s manufacturing process as opposed to the drug itself. Now that’s an achievement!

For his part, Gonzalez has a little more than four months to take his victory lap, until COO Robert Michael takes the reins as CEO of AbbVie. Michael was credited in a statement this week by Gonzalez with creating AbbVie’s financial planning organization, which developed the company’s business strategy for “successfully navigating the end of exclusivity for Humira in the U.S.” Hats off to you, gents! Other drug executives will be studying for years to come how AbbVie navigated the decline of Humira.

Greg Slabodkin is the News Editor at BioSpace. You can reach him at Follow him on LinkedIn. 

Greg Slabodkin is the News Editor at BioSpace. You can reach him at Follow him on LinkedIn.