FDA approves first interchangeable Humira biosimilar to Humira

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, SVP of medicine and regulatory affairs at Boehringer Ingelheim, in a statement. “The Interchangeability status of Cyltezo reinforces our goal of expanding overall treatment options and contributing to the quality and sustainability of the U.S. healthcare system.”

In July, Semglee (insulin glargine-yfgn) from Mylan and Biocon Biologics became the first interchangeable biosimilar insulin product.

Cyltezo is the first interchangeable monoclonal antibody to win FDA backing.

FDA created the biosimilar and interchangeable approval pathway to “help increase access to treatment options for patients with serious medical conditions,” said acting FDA Commissioner Dr. Janet Woodcock, in a statement.