For a second time, the Food and Drug Administration has rejected Alvotech’s Humira biosimilar, citing deficiencies spotted during a March inspection of its manufacturing facility in Iceland, the company said Thursday.
The agency’s decision comes less than three months before Alvotech is free to launch the drug in the U.S. under a settlement with AbbVie, Humira’s manufacturer. Alvotech has a second FDA application pending that, if approved by June 28, would make it one of the first “interchangeable” Humira biosimilars, meaning pharmacists could directly substitute it for the branded product.
