Boehringer Ingelheim fought hard against AbbVie’s so-called patent thicket surrounding the world’s bestselling drug, Humira. But in the end, the German company ended up settling, just like its fellow biosimilar makers.
With a Tuesday agreement, Boehringer joins a herd of companies who've agreed to sideline their Humira biosims until 2023.
AbbVie said Tuesday the two sides agreed to a July 1, 2023, rollout date. Boehringer had been the lone holdout as numerous other biosim players inked settlement after settlement.
After AbbVie sued Boehringer for patent infringement—a routine ordeal for biosim players seeking to reach the market—the German company sued back, claiming the Humira maker acted inequitably by pursuing overlapping and noninventive patents on the blockbuster immunology drug. The case had been mired in a lengthy fight over documents related to the dispute.
Thanks to the latest settlement, AbbVie’s Humira looks safe in the U.S. until 2023, even as biosimilars have started eating away at the drug’s European sales. After the EU copycats launched last fall, AbbVie reported a 23% decline in first-quarter Humira sales outside of the U.S., to $1.23 billion. The drug's U.S. sales grew 7% to $3.2 billion.
As of now, Amgen will have the first crack at Humira’s lucrative U.S. market. That company was the first to strike a patent settlement with AbbVie and secured a Jan. 31, 2023, launch date. On the other end of the spectrum, Pfizer late last year inked the seventh patent deal with AbbVie, agreeing to a Nov. 20, 2023, biosimilar rollout.
Humira generated $19.9 billion globally last year, falling just short of the $20 billion threshold executives had hoped for. As biosims take hold in Europe—and as pricing remains a key topic in the U.S.—it remains to be seen how the drug will perform before its U.S. patent cliff arrives.
In the meantime, AbbVie has a new psoriasis launch underway in Skyrizi and expects another immunology launch later this year in upadacitinib. Beyond immunology, the company has made oncology a focus, partly through its Pharmacyclics buyout that brought hematology drug Imbruvica into the fold. In the first quarter alone, that drug pulled in more than $1 billion. Venclexta is also gaining steam, pulling in $151 million in the first quarter.