Boehringer Ingelheim Pharmaceuticals announced a resolution of its litigation with AbbVie, that will continue to delay its introduction of a “biosimilar” alternative to the AbbVie blockbuster drug Humira.
Under the agreement, Boehringer Ingelheim will be able to begin selling its Cyltezo alternative to Humira beginning in July 2023.
Boehringer Ingelheim is based in Germany with its U.S. pharmaceutical headquarters in Ridgefield. The settlement is limited to U.S. sales only, with the companies not providing financial terms of their licensing agreement except to state that Boehringer Ingelheim will pay AbbVie royalties on Cyltezo.
Doctors prescribe Humira to treat multiple ailments, including severe rheumatoid arthritis and the inflammatory bowel syndrome Crohn’s disease. About one in five Connecticut residents suffer from arthritis, according to estimates by the the U.S. Centers for Disease Control & Prevention, with Crohn’s disease affecting about 3.1 million Americans.
Humira generated more than $19.9 billion in sales last year for North Chicago, Ill.-based AbbVie, representing an 8 percent overall increase but with international sales having tailed off sharply due to biosimilar competition in Europe and other regions. In the first quarter of this year, U.S. sales of Humira were up 7 percent to $3.2 billion.
In 2009, Congress authorized the Food & Drug Administration to approve biosimilars like Boehringer Ingelheim’s Cyltezo, creating a shortened approval process as a way to boost competition and by extension lower drug prices. The FDA approved the first biosimilar drug in 2015 and nearly 20 more since, including Cyltezo in 2017.
AbbVie has pursued a legal battle to slow the introduction of Humira competitors, however, with most of those rivals reaching settlements last year including Pfizer but with Boehringer Ingelheim choosing at the time to continue to assert its rights to sell Cyltezo.
In December, a Boehringer Ingelheim spokesperson told Hearst Connecticut Media the company was committed to making Cyltezo available in the United States “as soon as possible and certainly before 2023.” Boehringer Ingelheim did not respond immediately Tuesday to a Hearst Connecticut Media query on why it chose to take a settlement that allows it to market Cylzeto that year, rather than seek a trial on its case with the goal of accelerating that timeline.
Boehringer Ingelheim plans to manufacture Cyltezo injections at a plant in Fremont, Calif., with the company having invested $220 million to prepare the facility for mass production.
The respiratory medicine Spiriva led Boehringer Ingelheim drug sales last year, contributing $2.7 billion to the company’s $14.1 billion in total revenue. Boehringer Ingelheim spent more than $3 billion last year on research and development.
Alex.Soule@scni.com; 203-842-2545; @casoulman