Autoimmune disorder

FDA approves Humira biosimilar as first-ever interchangeable monoclonal antibody

Boehringer Ingelheim has shown biosimilar manufacturers the way to win interchangeability with the world’s highest-grossing drug — but the company’s Cyltezo won’t come out until July 2023. Will future Humira competitors have better luck winning an earlier launch date?

Better late than never? Eczema drug now approved, Incyte says warning unwarranted

Atopic dermatitis patients now have a new option that comes as a topical cream. The FDA approved Incyte’s drug, Opzelura, as a treatment for the inflammatory skin condition, but the regulatory nod comes with a black box warning on the label that broadly covers the entire class of JAK inhibitors.