Posted by Michael Wonder on 06 Oct 2023
FDA grants interchangeable designation to Pfizer’s biosimilar Abrilada
5 October 2023 - Interchangeable designation supported by positive data from the REFLECTIONS B538-12 study.
Pfizer today announced that the US FDA has designated Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab). The interchangeable designation applies to all approved indications of Abrilada, including certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.
