Table 1. . Characteristics of Humira® formulations and adalimumab biosimilars.
Humira® | Humira® (citrate free) | Amgevita®/Amjevita® | Imraldi®/Hadlima® | Hyrimoz® | Hulio® | Idacio® | Amsparity® | Yuflyma® | Hukyndra® | |
---|---|---|---|---|---|---|---|---|---|---|
EU/US market† | EU/US | EU/US | EU/US‡ | EU/US | EU/US | EU | EU | EU | EU/US | EU |
Needle size (G) syringe | 27 | 29 | 29 | 29 | 27 | 29 | 29 | 29 | 29 | 29 |
Needle size (G) pen | 27 | 29 | 27 | 29 | 27 | 29 | 29 | 29 | 29 | 29 |
Pre-filled syringe/pen | 40 mg/- | 20 mg, 40 mg, 80 mg/ 40 mg, 80 mg |
20 mg, 40 mg/40 mg |
40 mg/ 40 mg |
20 mg, 40 mg, 80 mg/ 40 mg, 80 mg |
20 mg, 40 mg/ 40 mg |
40 mg/ 40 mg |
20 mg, 40 mg/40 mg |
40 mg, 80 mg/ 40 mg, 80 mg |
40 mg, 80 mg/ 40 mg |
Citrate | Yes | No | No | No§ | No | No | Yes | No | No | No |
Latex | Yes | No | Yes | No | No | No | No | No | No | No |
Volume (ml) for 40 mg dose | 0.8 | 0.4 | 0.8 | 0.4 | 0.4 | 0.8 | 0.8 | 0.8 | 0.4 | 0.4 |
Availability of 80 mg formulation | No | Yes (since 16 Dec 2021) | No | No | No | No | No | No | Yes | Yes (syringe only) |
Shelf life at 25°C, days | 14 | 14 | 14 | 31 | 21 | 14 (20 mg in 0.4 ml sterile solution), 56 (40 mg in 0.8 ml sterile solution) |
28 | 30 (at 30°C) | 31 | 14 |
As at 4 July 2023.
High-concentration formulation expected to reach US market in 2024.
Imraldi®/Hadlima® has been citrate-free since the beginning of 2023.