2023 is a busy year for the U.S. biosimilars market. The market has seen a number of new biosimilars launch that reference Humira®, one of the top selling drugs in the world. Since its launch, Humira® has evolved from its original, low concentration (50mg) citrate version to a high concentration (100mg) citrate-free version. The biosimilars that have launched and are in development in reference to Humira® have differing product attributes from low concentration (50mg) vs high concentration (100mg) and citrate vs citrate free versions. Humira® biosimilars have launched with varying WAC prices, with discounts ranging from 5% up to 86%.
We believe in the promise of biosimilars to deliver cost savings across healthcare. We also understand the potential hurdles these unique products will face. Our guide to biosimilars* that reference Humira® is designed to help providers and patients navigate this changing market.
Launched in the United States
| Company | Product name | Launch date | Interchangeability status | Safety Information | Concentration | Citrate free | WAC Price |
| Amgen | Amjevita™ | Dec 12, 2023 | Read more | 100MG | Yes | $1,385.22 | |
| Amgen1 | Amjevita™ | Jan 31, 20231 | Read more | 50MG2 | Yes1 | $6,922.62 | |
| Amgen1 | Amjevita™ | Jan 31, 20231 | Read more | 50MG2 | Yes1 | $3,115.18 | |
| Boehringer Ingelheim22 | adalimumab-adbm | October 2, 202322 | Approved22 | Read more | 50MG22 | Yes22 | $1,315.30 |
| Boehringer Ingelheim7 |
Cyltezo® | July 1, 20237 | Approved7 | Read more | 50MG8 | Yes7 | $6,576.49 |
| Celltrion |
Yuflyma | July 1, 2023 | Read more | 100MG | Yes | $6,576.50 | |
| Coherus9 | Yusimry™ | July 1, 2023 r9 | Read more |
50MG9 | Yes10 |
$995.00 | |
| Fresenius | Adalimumab-aacf | January 15, 2024 | Read more | 50MG | Yes | $899.00 | |
| Fresenius Kabi19 | Idacio® | July 1, 202319 | Read more | 50MG21 | Yes19 | $6,576.49 | |
| Organon4 | Hadlima™ | July 1, 2023 5 | Read more | 50MG6 | No6 | $1,038.00 | |
| Organon4 | Hadlima™ | July 1, 2023 18 | Read more | 100MG18 | Yes18 | $1,038.00 | |
| Pfizer15 |
Abrilada™ | November 1, 2023 | Approved |
Read more | 50MG17 | Yes16 | $6,576.49 |
| Pfizer15 |
Abrilada™ |
November 1, 2023 | Approved |
Read more | 50MG17 | Yes16 |
$2,769.05 |
| Sandoz20 | Hyrimoz™ |
July 1, 202320 |
Read more |
100MG20 |
Yes20 |
$6,576.49 |
|
| Sandoz20 |
adalimumab-adaz |
July 1, 202320 |
Read more |
100MG20 |
Yes20 |
$1,038.00 |
|
| Viatris11 | Hulio™ | July 1, 202311 | Read more | 50MG11 | Yes12 | $6,576.49 | |
| Viatris23 | adalimumab-fkjp | July 1, 202323 | Read more | 50MG23 | Yes23 | $995.00 |
*WAC price represents the price for a two pack of pens or pre-filled syringes
- 1 FDA Approves Amegen's Amjevita
- 2 AMJEVITA (adalimumab-atto) injection for subcutaneous
- 4FDA Accepts Samsung Bioepis’ and Organon’s sBLA
- 5Samsung Bioepis and Organon Seek to Enter the Market
- 6PrHADLIMA®
- 7 U.S. FDA Approves Cyltezo®
- 8Boehringer Ingelheim Bpcia Strength Petition
- 9Coherus Announces U.S. FDA Approval of YUSIMRY™
- 10YUSIMRY (adalimumab-aqvh) injection
- 11Mylan and Fujifilm Kyowa Kirin Biologics Announce U.S. FDA Approval of Hulio®
- 12HULIO® (adalimumab-fkjp) injection
- 13Sandoz receives US FDA approval for biosimilar Hyrimoz™
- 14HYRIMOZ (adalimumab-adaz) injection
- 18Samsung Bioepis and Organon Announce FDA Approval of Citrate-Free High-Concentration HUMIRA® Biosimilar HADLIMA™
- 19Fresenius Kabi receives U.S. FDA approval for biosimilar Idacio® (adalimumab)
- 20Sandoz receives US FDA approval for biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation
- 21 IDACIO® (adalimumab-aacf) injection
- 22 Adalimumab-adbm, Boehringer Ingelheim’s Interchangeable biosimilar to Humira®, now available at low wholesale acquisition cost
- 23 After Five Years of Successful Experience Internationally, Biocon Biologics’ Hulio® Biosimilar to Humira®, Now Available in the United States
*This page is intended to assist health care providers in navigating the complicated biosimilars landscape. It should not be used to make prescribing or treatment decisions. Some therapies on this page may not have been approved by the Food and Drug Administration (FDA) or have been cleared for specific uses only. It is the responsibility of the physician to determine the FDA clearance status of each therapy in clinical practice. Therefore, before prescribing any medication, please review the complete prescribing information including indications, contraindications, warnings, precautions and adverse effects.
15 FDA Approves Pfizer’s Biosimilar, ABRILADA™
16 FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™
17 ABRILADA- adalimumab-afzb
Updated: 10/06/2023
Additional resources
Biosimilar resources for providers
