Humira (adalimumab) was approved in 2002 by the Food and Drug Administration (FDA) and became a top selling biologic in the United States (U.S.). Biosimilar competition entered the market in July 2023 and impacted AbbVie’s financial performance. The company reported $12,160 billion in net revenue for Humira in the U.S. for 2023, a 35% decline from 2022.
FDA-approved biosimilars to Humira
There are currently ten FDA-approved biosimilars to Humira with nine that launched in 2023.* The most recent approval in February 2024 was Simlandi®. It is the first high-concentration, citrate-free interchangeable biosimilar to Humira.
Abrilada™ and Cyltezo® are low-concentration biosimilars to Humira with interchangeability status, and additional FDA-approved Humira biosimilars are seeking interchangeability with anticipated decisions in 2024.
Current interchangeablility status:
- Abrilada [Pfizer] - Interchangeable
- Cyltezo [Boehringer Ingelheim] - Interchangeable
- Hadlima™ [Organon] - Pending
- Hadlima HC™ [Organon] - Pending
- Simlandi [Alvotech] - Interchangeable
- Yuflyma™ [Celltrion] - Pending
Differences between Humira and biosimilars
There are some differences between Humira and the FDA-approved biosimilars with regard to FDA-approved indications. Only Humira has pediatric approval for the following indications: hidradenitis suppurativa, uveitis, and ulcerative colitis.
Other differences between the reference and biosimilar products that may affect selection include: concentration (e.g., 50 mg/mL or 100 mg/mL), device availability (e.g., prefilled syringe or pen device), and inactive ingredients (e.g., latex and citrate).
Unbranded Humira biosimilar products
Unbranded adalimumab products are marketed under a manufacturer’s approved Biologics License Applications (BLA) without its brand name on label. The FDA considers it to be equivalent to its brand name biological product.
Unbranded products available:
- Cyltezo [Boehringer Ingelheim] - Yes
- Hulio® [Mylan] - Yes
- Humira [AbbVie] - Yes, not launched
- Hyrimoz HCF™ [Sandoz] - Yes
- Idacio® [Fresenius Kabi] - Yes
- Yuflyma™ [Celltrion] - Yes, not launched
CarelonRx closely monitors the drug and biologic pipeline and provides this spotlight information as part of our mission to improve health, reduce waste, lower total cost of care, and estimate future cost impact.
* Projections on future drug approvals and availability are based on information available at the time of publication and are not within the control of CarelonRx. Unless otherwise noted, information contained in this article was obtained from the Centers for Disease Control and Prevention (CDC) (cdc.gov), the Food and Drug Administration (FDA) (fda.gov), clinicaltrials.gov, releases from pharmaceutical manufacturers, National Institutes of Health (NIH) (nih.gov), and UpToDate.com (registration required). Information in this article is accurate as of March 6, 2024.
