The New Era of Adalimumab: Beyond Humira
Humira, the brand name for the biologic drug adalimumab, has not been renamed. Instead, the question 'What is the new name for Humira?' points to the introduction of numerous FDA-approved biosimilars. Adalimumab is a biological medicine made from proteins that reduces inflammation by acting on the immune system by blocking a protein called tumor necrosis factor (TNF). For years, Humira was the sole adalimumab product available, but its patent expirations have paved the way for a new market of highly similar, and often more affordable, alternatives.
A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product, proven to be just as safe and effective as the original biologic. As of 2025, there are numerous adalimumab biosimilars available in the United States, including Amjevita, Hyrimoz, Cyltezo, and Yuflyma, among others.
Understanding Key Terminology
- Biologic: A medication made from a living source. Humira is a biologic.
- Biosimilar: A biologic medication highly similar to an FDA-approved biologic reference product with no meaningful clinical differences in safety, purity, and potency.
- Interchangeable Biosimilar: An FDA designation indicating a biosimilar can be switched with the reference product without increased risk or decreased efficacy. Subject to state laws, a pharmacist may substitute an interchangeable biosimilar for the reference product without prescriber consultation. Examples include Cyltezo, Abrilada, and Simlandi.
Conditions Treated by Adalimumab
Adalimumab and its biosimilars are approved to treat various inflammatory and autoimmune conditions. A list of conditions treated by Adalimumab can be found on {Link: Pfizer https://www.pfizer.com/news/announcements/fda-grants-interchangeable-designation-pfizers-biosimilar-abriladatm}.
Comparing Humira and its Biosimilars
Differences between Humira and its biosimilars primarily involve cost, insurance coverage, and specific formulations, not clinical effectiveness. Some biosimilars offer high-concentration, citrate-free formulas, potentially leading to smaller injection volumes and less pain compared to the original citrate-containing, lower-concentration Humira.
Here is a comparison of some key adalimumab products:
Feature | Humira (Reference Product) | Amjevita (adalimumab-atto) | Cyltezo (adalimumab-adbm) | Hyrimoz (adalimumab-adaz) | Simlandi (adalimumab-ryvk) |
---|---|---|---|---|---|
Manufacturer | AbbVie | Amgen | Boehringer Ingelheim | Sandoz | Alvotech/Teva |
Interchangeable? | N/A (Reference) | Yes (certain presentations) | Yes | Yes (certain presentations) | Yes |
Formulation | Low & high-concentration, citrate-free available | Low & high-concentration, citrate-free | Low & high-concentration, citrate-free | Low & high-concentration, citrate-free | High-concentration, citrate-free |
FDA Approval | December 31, 2002 | September 23, 2016 | August 25, 2017 | October 30, 2018 | February 23, 2024 |
Important Safety Considerations
Adalimumab products, as TNF blockers, suppress the immune system, increasing the risk of serious, potentially fatal, infections like tuberculosis, fungal, and bacterial infections. They may also increase the risk of certain cancers, such as lymphoma. Patients require latent TB testing before treatment and close monitoring for infection. Discuss all health conditions and risks with a healthcare provider before starting any adalimumab product.
Conclusion: A New Landscape of Choice
Humira does not have a single "new name." Instead, the market now includes multiple biosimilar and interchangeable adalimumab products. This expansion aims to lower costs and increase treatment options for patients and doctors. The availability of different formulations and devices allows for personalized treatment. While clinical efficacy and safety are comparable, factors like insurance, cost, and patient preference may influence the final choice.
For more information from an authoritative source, you can visit the FDA's page on Biosimilar and Interchangeable Biologics.