Last year, Humira (adalimumab) was the top-selling drug in the U.S., racking up nearly $20 billion in international sales.
Now, Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) has become the first interchangeable Humira biosimilar.
First winning FDA approval in August 2017, Cyltezo is a tumor necrosis factor blocker indicated for everything from arthritis to Crohn’s, ulcerative colitis and plaque psoriasis.
The FDA decided to grant interchangeable status to Cyltezo based on Phase 3 randomized VOLTAIRE-X clinical trial.
FDA allows interchangeable biosimilars to be substituted for the reference product without the prescriber modifying the prescription.
“We are proud to be the company driving the advancement of biosimilars and delivering the first and only Interchangeable biosimilar with Humira,” said Thomas Seck, senior vice president, medicine and regulatory affairs at Boehringer Ingelheim, in a statement. “The Interchangeability status of …