Cyltezo
Adalimumab biosimilar developed by Boehringer Ingelheim, development code BI 695501. Reference product Humira.
About Cyltezo
Cyltezo is Boehringer Ingelheim's adalimumab. It was the first adalimumab biosimilar to be designated interchangeable in the United States, in October 2021, and held that status alone for two years. In Europe it was approved in 2017 but the company withdrew the licence in 2019 and never launched there. The product is available in both the original and the high-concentration form.
Status by market
United States · Cyltezo
US Food and Drug AdministrationApprovedEuropean Union · Cyltezo
European Medicines Agency and European CommissionWithdrawnUnited Kingdom
Not listed by MHRA.
Japan
Not listed by PMDA.
Canada
Not listed by HC.
India
Not listed by CDSCO.
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Cyltezo holds an approval, these are the other adalimumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 9 | Alvotech (Simlandi / Hukyndra / Libmyris), Amgen (Amjevita / Amgevita), Celltrion (Yuflyma), Coherus BioSciences (Yusimry), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Pfizer (Abrilada / Amsparity), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya) |
Chronology
- FDAAug 2017Approved by FDA as Cyltezo
- EMAJan 2019Cyltezo authorisation withdrawn
- FDAOct 2021Cyltezo designated interchangeable
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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