FDA Approves Interchangeable Status for BI’s Adalimumab Biosimilar Cyltezo

BI’s adalimumab biosimilar CYLTEZO (adalimumab-adbm) has recently been granted interchangeable status by the FDA.  Although approved in August 2017, CYLTEZO is not scheduled to launch until July 1, 2023, pursuant to a settlement agreement with AbbVie arising from the Humira litigation.  CYLTEZO is now the second interchangeable biosimilar approval granted by the FDA; as we previously reported, SEMGLEE received interchangeable approval in July 2021.

Although several adalimumab biosimilars are scheduled to launch in 2023, CYLTEZO is the first to gain interchangeable status.  In a statement, BI announced that “[w]e are proud to be the company driving the advancement of biosimilars and delivering the first and only Interchangeable biosimilar with Humira.”