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AbbVie’s blockbuster weighed down by safety concerns for a similar Pfizer drug

For years, AbbVie’s business has relied on Humira. One of the world’s top-selling medicines, Humira brought in close to $20 billion for AbbVie in each of the last three years, accounting for at least 40% of the company’s annual net revenue.

Yet, the patents that have long protected Humira from copycat drugs won’t last indefinitely. In fact, the company has made agreements with generic manufacturers to allow Humira biosimilars to enter the U.S. market in 2023. Revenue from the drug has already fallen in some international markets where biosimilars are approved.

AbbVie, though, has been preparing for a post-Humira future, with one of its most important assets being Rinvoq. Unlike Humira, which is a TNF blocker, Rinvoq targets a type of enzyme called a Janus kinase, or JAK. It was first approved in August 2019 for patients with moderate-to-severe rheumatoid arthritis, and is currently being evaluated in many of the other diseases Humira treats, including Crohn’s, ulcerative colitis and several more kinds of arthritis.

Over the first nine months of this year, Rinvoq generated $1.1 billion in net revenue — more than double what it had earned during the same period in 2020. AbbVie has estimated that combined sales from Rinvoq and Skyrizi, another relatively new addition to the company’s portfolio of immunology drugs, will surpass $10 billion by 2025.

However, the Xeljanz study and the FDA’s reaction to it have led some analysts to lower their sales expectations for the marketed JAK inhibitors. The team at SVB Leerink, for example, updated their Rinvoq model a few months ago, lowering the drug’s revenue potential by around $900 million by 2025.

SVB analyst Geoffrey Porges wrote in a note to clients that Rinvoq’s updated label appears to have milder, “more favorable” language with regard to some of the safety warnings when compared to Xeljanz. For example, it notes that the higher rates of cancer and major cardiovascular events were seen with a different JAK inhibitor.

Even so, “these are all minor wins in light of the major scrutiny on the JAK inhibitor class over the last year, and with the updated labels, the FDA has made it clear that they believe [major cardiovascular events], malignancy, and thrombosis to be class effects for JAKs,” Porges wrote.

Pfizer has also amended the label on Xeljanz to align with the FDA’s requirements. Lilly has yet to update the Olumiant label.

Porges wrote that his team continues to believe AbbVie is in a better position with Rinvoq than Pfizer and Lilly are with their respective JAK drugs.