Most Common Humira Biosimilars
Humira (adalimumab), AbbVie's blockbuster arthritis and autoimmune drug, faces multiple biosimilars approved by the FDA since 2023. The most commonly referenced by name, prescriptions, and market share in the US include Hadlima, Yusimry, and Cyltezo. These have gained traction due to early approvals and interchangeable status, allowing pharmacy substitution for Humira.[1]
| Biosimilar Name | Manufacturer | Key Notes |
|-----------------|--------------|-----------|
| Hadlima | Samsung Bioepis / Organon | First interchangeable Humira biosimilar (July 2023); available in citrate-free high-concentration form matching Humira's popular version. Highest US market share among biosimilars (~40% as of mid-2024). |
| Yusimry | Coherus BioSciences | Approved Jan 2023; first non-interchangeable but widely dispensed; lowest list price (~$1,300/month vs. Humira's $6,900). |
| Cyltezo | Boehringer Ingelheim | First interchangeable (Oct 2022, launch July 2023); near-identical to Humira with same syringe design. |
| Amjevita | Amgen | Approved 2016 but delayed by patents until Jan 2023; multiple formulations including NuvFilma autoinjector. |
| Simlandi | Teva / Alvotech | Interchangeable, launched June 2024; strong uptake in Europe as Selbee. |
These five dominate US discussions and sales data, with Hadlima leading due to accessibility.[2]
How These Compare to Original Humira
All are highly similar to Humira in efficacy, safety, and immunogenicity per FDA approvals, with clinical trials showing bioequivalence (e.g., 80-125% confidence intervals for AUC and Cmax). Interchangeables like Hadlima and Cyltezo can be auto-substituted without prescriber changes in most states, driving ~85% drop in Humira's US market share since 2023.[3]
Availability Outside the US
In Europe (approved since 2018), common names include Amgevita (Amgen), Imraldi (Samsung), Hyrimoz (Sandoz), and Hulio (Mylan). Canada has Hadlima and others since 2022. Global launches vary by patent settlements.[1]
When Did Patents Expire and What's Left?
AbbVie settled 100+ patent suits, allowing staggered US entries: non-interchangeables Jan 2023, interchangeables July 2023. Key patents expired 2023; last exclusivity ends 2025-2034 for kids' formulations. No major litigation blocks current players.[4]
[1]: FDA Humira Biosimilars List
[2]: DrugPatentWatch.com - Humira Biosimilars
[3]: Evaluate Pharma Market Data
[4]: USPTO Patent Database