Hadlima / Imraldi
Adalimumab biosimilar developed by Samsung Bioepis, development code SB5. Reference product Humira.
About Hadlima / Imraldi
Hadlima is Samsung Bioepis's adalimumab, marketed by Organon in the United States and by Biogen in Europe, where it is called Imraldi. Imraldi was among the first European adalimumab biosimilars to launch, in 2018, and took a large share in several countries. In the United States it was approved in 2019, launched in 2023 and is interchangeable. It is available as a syringe and as the PushTouch pen.
Status by market
United States · Hadlima
US Food and Drug AdministrationApprovedEuropean Union · Imraldi
European Medicines Agency and European CommissionApprovedUnited Kingdom · Imraldi
Medicines and Healthcare products Regulatory AgencyApprovedJapan
Not listed by PMDA.
Canada · Hadlima
Health CanadaApprovedIndia
Not listed by CDSCO.
United Arab Emirates
Not listed by EDE.
Trials behind this product
Comparative trials on ClinicalTrials.gov matched to Hadlima / Imraldi by development code, brand or developer. Registry data, sponsor-entered.
| Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | Registry record |
|---|---|---|---|---|---|---|---|---|
| SB5 | Samsung Bioepis | Humira | Phase 4 | Comparative PK | Completed | Aug 2022 | Apr 2023 | NCT05510063 |
| SB5 | Samsung Bioepis | Humira | Phase 3 | Comparative efficacy | Completed | May 2014 | Apr 2015 | NCT02167139 |
Other developers in the same markets
Where Hadlima / Imraldi 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), Boehringer Ingelheim (Cyltezo), Celltrion (Yuflyma), Coherus BioSciences (Yusimry), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Pfizer (Abrilada / Amsparity), Sandoz (Hyrimoz / Hefiya) |
| EMA | 7 | Alvotech (Simlandi / Hukyndra / Libmyris), Amgen (Amjevita / Amgevita), Celltrion (Yuflyma), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Pfizer (Abrilada / Amsparity), Sandoz (Hyrimoz / Hefiya) |
| MHRA | 7 | Alvotech (Simlandi / Hukyndra / Libmyris), Amgen (Amjevita / Amgevita), Celltrion (Yuflyma), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Not stated in the MHRA list (Qletli), Sandoz (Hyrimoz / Hefiya) |
| HC | 7 | Alvotech (Simlandi / Hukyndra / Libmyris), Amgen (Amjevita / Amgevita), Celltrion (Yuflyma), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Pfizer (Abrilada / Amsparity), Sandoz (Hyrimoz / Hefiya) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Samsung Bioepis: Aybintio, Byooviz, Epysqli, Eticovo / Benepali, Ontruzant, Opuviz, Ospomyv / Xbryk / Obodence, Pyzchiva, Renflexis / Flixabi.
Chronology
- EMAAug 2017Authorised by the European Commission as Imraldi
- HCMay 2018Notice of Compliance, Health Canada as Hadlima
- FDAJul 2019Approved by FDA as Hadlima
- FDAJun 2024Hadlima 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)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
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