Table.
Biosimilars Currently Available in the United States for Inflammatory Bowel Disease Treatment
| Biosimilar | Manufacturer | FDA approval | Indications |
|---|---|---|---|
| Infliximab biosimilars | |||
| Avsola (infliximab-axxq) | Amgen | 2019 | CD (adult/pediatric), UC (adult/pediatric), RA, AS, PsA, Ps |
| Inflectra (infliximab-dyyb) | Pfizer | 2016 | CD (adult/pediatric), UC (adult/pediatric), RA, AS, PsA, Ps |
| Renflexis (infliximab-abda) | Organon | 2017 | CD (adult/pediatric), UC (adult/pediatric), RA, AS, PsA, Ps |
| Adalimumab biosimilars a | |||
| Abrilada (adalimumab-afzb)b | Pfizer | 2019 | RA, JIA, PsA, AS, CD, UC, Ps, HS, UV |
| Amjevita (adalimumab-atto)c-d | Amgen | 2016 | RA, JIA, PsA, AS, CD, UC, Ps, HS, UV |
| Cyltezo (adalimumab-adbm)b-d | Boehringer Ingelheim | 2017 | RA, JIA, PsA, AS, CD, UC, Ps, HS, UV |
| Hadlima (adalimumab-bwwd)d | Organon/ Samsung Bioepis | 2019 | RA, JIA, PsA, AS, CD, UC, Ps, HS, UV |
| Hulio (adalimumab-fkjp)c | Mylan/Fujifilm Kyowa Kirin Biologics | 2020 | RA, JIA, PsA, AS, CD, UC, Ps, HS, UV |
| Hyrimoz (adalimumab-adaz)b-d | Sandoz | 2018 | RA, JIA, PsA, AS, CD, UC, Ps, HS, UV |
| Idacio (adalimumab-aacf ) | Fresenius Kabi | 2022 | RA, JIA, PsA, AS, CD, UC, Ps, HS, UV |
| Simlandi (adalimumab-ryvk)b | Alvotech/Teva | 2024 | RA, JIA, PsA, AS, CD, UC, Ps, HS, UV |
| Yuflyma (adalimumab-aaty) | Celltrion | 2023 | RA, JIA, PsA, AS, CD, UC, Ps, HS, UV |
| Yusimry (adalimumab-aqvh) | Coherus BioSciences | 2021 | RA, JIA, PsA, AS, CD, UC, Ps, HS, UV |
aFor UC, HS, and UV, adalimumab biosimilars are indicated for adults only, whereas the reference product is indicated for adults and pediatric pts.
bContains interchangeable designation and could be substituted for reference product at pharmacy level.
cHas unbranded formulation available.
dBoth high and low formulations are available; the low formulation may not be citrate-free.
AS, ankylosing spondylitis; CD, Crohn’s disease; FDA, US Food and Drug Administration; HS, hidradenitis suppurativa; JIA, juvenile idiopathic arthritis; Ps, plaque psoriasis; PsA, psoriatic arthritis; pts, patients; RA, rheumatoid arthritis; UC, ulcerative colitis; UV, uveitis.