The End of an Era: Humira's Patent Expiry
For years, Humira (adalimumab) by AbbVie stood as a cornerstone treatment for a range of autoimmune diseases, including rheumatoid arthritis, plaque psoriasis, and Crohn's disease [1.2.2, 1.2.3]. It was once the world's top-selling drug [1.8.4]. However, the expiration of its primary patents has opened the door to a new class of drugs: biosimilars. This shift is significantly altering the market, leading to a substantial decrease in Humira's sales and market share as new, more affordable options become available [1.8.1, 1.8.3]. In the first year of competition alone, adalimumab net spending dropped by nearly 50% [1.8.1].
Understanding Biosimilars
Before diving into the specific replacements, it's crucial to understand what a biosimilar is. Unlike generic drugs, which are exact chemical copies of their brand-name counterparts, biosimilars are 'highly similar' to the original biologic drug they reference (in this case, Humira) [1.10.3]. Biologics are complex molecules produced from living sources like yeast or animal cells [1.10.4]. Due to this complexity, biosimilars are not identical copies but have no clinically meaningful differences in terms of safety, purity, and potency from the reference product [1.10.2]. They undergo a rigorous FDA approval process to ensure they are just as safe and effective [1.4.1].
The Rise of Interchangeable Biosimilars
A key development in the biosimilar landscape is the designation of "interchangeability" by the FDA. An interchangeable biosimilar can be substituted for the original reference product at the pharmacy without needing to consult the prescribing doctor, similar to how generic drugs are dispensed [1.4.3]. This requires additional studies to prove that switching between the reference product and the biosimilar causes no additional risk or reduced efficacy [1.5.2].
As of 2025, there are several FDA-approved adalimumab biosimilars, with a growing number achieving interchangeable status [1.3.2]. Recent examples include Yuflyma (adalimumab-aaty) and Simlandi (adalimumab-ryvk), which are also offered in high-concentration, citrate-free formulations for a less painful injection experience [1.5.1, 1.6.2]. The high-concentration version now accounts for the majority of the adalimumab market [1.6.3].
Comparing the Humira Replacements
As of late 2025, the U.S. market has around 10 adalimumab biosimilars competing with Humira [1.2.4]. These options vary in several key aspects that are important for both patients and providers to consider.
| Feature | Humira (Reference) | Amjevita (adalimumab-atto) | Cyltezo (adalimumab-adbm) | Simlandi (adalimumab-ryvk) | Yuflyma (adalimumab-aaty) | Hyrimoz (adalimumab-adaz) |
|---|---|---|---|---|---|---|
| Manufacturer | AbbVie | Amgen | Boehringer Ingelheim | Alvotech/Teva | Celltrion | Sandoz |
| FDA Approval | 2002 | 2016 | 2017 | 2024 | 2023 | 2018 |
| Interchangeable? | N/A | Yes (certain presentations) [1.3.2] | Yes (certain presentations) [1.3.2] | Yes [1.3.3, 1.6.2] | Yes [1.5.1] | Yes (certain presentations) [1.3.2] |
| Concentration | Low & High | Low & High [1.3.3] | Low & High [1.6.5] | High [1.3.3] | High [1.3.3] | Low & High [1.3.3] |
| Citrate-Free? | High-conc. is CF [1.4.4] | Yes [1.3.3] | Yes [1.4.3] | Yes [1.3.3] | Yes [1.3.3] | High-conc. is CF [1.3.3] |
This table is not exhaustive and represents a selection of available biosimilars. Data is compiled from multiple sources [1.3.2, 1.3.3, 1.4.4, 1.5.1, 1.6.2, 1.6.5].
The Impact on Cost and Access
The primary driver for adopting biosimilars is cost reduction. Biosimilars are introduced at significant discounts compared to Humira's list price, with some offering reductions of over 85% [1.7.2]. For example, Yusimry launched at $995 per carton, compared to Humira's price of $6,922 [1.7.2]. This competition has prompted major pharmacy benefit managers (PBMs) like CVS to remove Humira from their standard formularies in favor of biosimilars, a move that significantly accelerated biosimilar uptake [1.8.1, 1.9.4].
However, the pricing landscape is complex. Some manufacturers have launched dual-pricing strategies: a high list price with high rebates for PBMs and a low list price with smaller rebates, which can offer lower out-of-pocket costs for patients [1.4.5]. The introduction of these lower-cost alternatives is a critical step toward making these essential biologic treatments more accessible and affordable [1.11.2].
The Future: Beyond Humira
While numerous biosimilars are replacing Humira, the market continues to evolve. AbbVie, Humira's manufacturer, has shifted focus to newer immunology products like Skyrizi (risankizumab) and Rinvoq (upadacitinib), which have shown superior efficacy in some head-to-head trials against Humira [1.2.4]. This strategy, sometimes called "product hopping," aims to move patients to newer, patent-protected drugs before biosimilar competition fully takes hold [1.2.4, 1.11.3]. Despite this, the global adalimumab biosimilar market is projected to grow substantially, driven by cost-effectiveness and increasing patient demand [1.11.2].
Conclusion
There isn't a single medication replacing Humira, but rather a robust and growing market of adalimumab biosimilars. Led by interchangeable, high-concentration, and citrate-free options like Simlandi and Yuflyma, these alternatives offer comparable safety and efficacy with the major benefit of significant cost savings. As more biosimilars enter the market and gain formulary acceptance, patients now have an expanding array of more affordable treatments for chronic autoimmune conditions. The conversation with a healthcare provider is the best way to determine the most suitable option for an individual's specific needs.
For more information from the FDA on biosimilars, visit the FDA's Biosimilar Product Information Page.
