Even after many biosimilar players inked patent settlements with Humira maker AbbVie, Boehringer Ingelheim held out to challenge AbbVie's "patent thicket" in court. Although Boehringer eventually settled, the company's copycat has now scored an "interchangeable" designation—a landmark development that shows it could be a formidable competitor, one analyst writes.
Boehringer on Friday said its drug Cyltezo had scored FDA approval as the first interchangeable Humira biosimilar. Boehringer can't launch until July 1, 2023, under its patent settlement with AbbVie, but when it does, the designation means pharmacists can substitute Cyltezo for Humira at the pharmacy counter.
Until now, every biosimilar approved has needed a prescription specifically for that biosimilar itself. Interchangeability means biosimilars can be treated like small-molecule generics, subbing in for their reference brands at will.
So, the approval isn't only important for the Humira biosimilar market, Bernstein analyst Ronny Gal pointed out to clients Monday. It's a "landmark achievement" for the entire field because it's the first interchangeable monoclonal antibody—and most drugs that biosimilars target are monoclonal antibodies, or mAbs. The news shows the FDA has now established requirements for interchangeable approvals.
"This will facilitate future approvals for other drugs, and we wonder if in the long run, interchangeable biosimilars will be the only biosimilars" for mAb drugs, he added.
Meanwhile, specific to the Humira market, Gal said Boehringer "should not be under-appreciated" because it has "significant biological manufacturing and U.S. commercial capacities." In the U.S., Boehringer Ingelheim has thousands of employees and a manufacturing presence in Fremont, California. The company also just opened a massive production site in Austria.
But Boehringer won't be the first to access the lucrative U.S. Humira market. Under a 2017 deal, Amgen appears to be set up to launch the first Humira biosimilar on January 31, 2023. Merck and partner Samsung Bioepis negotiated a license that starts on June 30 of that year. Boehringer could follow up a day later. AbbVie's blockbuster generated more than $16 billion in the U.S. last year, indicating the size of the market at stake.
One holdout still aims to challenge AbbVie's patents in court. Iceland's Alvotech is locked in a lawsuit with AbbVie, and the court aims to rule on that case by the end of next October. Alvotech is also pursuing an interchangeable designation and has completed a successful switching study for its candidate.