FDA Approves Interchangeable Status for BI’s Adalimumab Biosimilar Cyltezo

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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.”

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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