FDA approves Abrilada as second interchangeable adalimumab biosimilar (Healio)

The FDA has granted approval to Abrilada, making it the second interchangeable biosimilar to adalimumab. This decision allows Abrilada (adalimumab-afzb, Pfizer) to be substituted for adalimumab (Humira, Abbvie) at the pharmacy level without the need for intervention or notification of the prescribing provider, in states where it’s permitted. The biosimilar is approved for various conditions including rheumatoid arthritis, juvenile idiopathic arthritis, and Crohn’s disease, among others. The FDA’s approval was based on data from the phase 3 REFLECTIONS B538-12 study, which showed similar outcomes between the reference product and Abrilada. Pfizer plans to make Abrilada available by late October, initially pricing it at 5% less than the originator adalimumab, and later at a rate 60% lower than the originator list price.