Approval alert: FDA approves Boehringer’s Cyltezo® (adalimumab) autoinjector pen

May 21, 2023

Boehringer Ingelheim announced that the FDA has approved an autoinjector pen presentation of its Cyltezo® (adalimumab-adbm), an FDA-approved interchangeable biosimilar to AbbVie’s Humira® (adalimumab). Cyltezo® is indicated for multiple chronic inflammatory diseases.  The autoinjector pens will be available in the US from 1 July 2023.

Boehringer is licensed to supply its adalimumab biosimilar in the US from 1 July 2023.  In total, AbbVie entered into numerous deals with biosimilar entrants enabling US market entry as follows: Samsung Bioepis/Merck (30 June 2023),  Alvotech (1 July 2023), Coherus (1 July 2023),  Celltrion (July 2023),  Fresenius Kabi (July 2023),  Mylan/Viatris (31 July 2023), Sandoz (30 September 2023), Momenta (20 November 2023), and Pfizer (20 November 2023).

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