Skip to content

What is the new name for Humira? Understanding Adalimumab Biosimilars

3 min read

Since January 2023, at least nine biosimilars for Humira (adalimumab) have entered the U.S. market, creating more treatment options. So, what is the new name for Humira? The answer is not one name, but many.

Quick Summary

Humira has not been renamed. Instead, multiple FDA-approved 'biosimilar' versions are now available. These medications are highly similar in safety and efficacy and offer new options for patients.

Key Points

  • No Single New Name: Humira has not been renamed; rather, multiple FDA-approved biosimilars are now available.

  • What are Biosimilars?: Biosimilars are highly similar versions of an original biologic drug (like Humira) with no clinically meaningful differences in safety or effectiveness.

  • Interchangeable Status: Some biosimilars, like Cyltezo and Simlandi, are 'interchangeable,' meaning a pharmacist can substitute them for Humira without consulting the prescriber, depending on state law.

  • Key Differences: Variations between products often involve formulation (high vs. low concentration, citrate-free) and injection devices, not clinical efficacy.

  • Cost and Access: The introduction of biosimilars is intended to increase competition and potentially lower costs for patients and the healthcare system.

  • Consistent Treatment: Adalimumab, whether Humira or a biosimilar, treats the same inflammatory conditions like rheumatoid arthritis, Crohn's disease, and psoriasis by blocking TNF.

  • Safety Profile: All adalimumab products, including Humira and its biosimilars, carry the same risks, such as an increased chance of serious infections.

In This Article

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.

Frequently Asked Questions

Biologic drugs like Humira do not have 'generics' in the way small-molecule drugs do. Instead, they have 'biosimilars,' which are highly similar and have no clinically meaningful differences in safety and effectiveness from the original product.

A biosimilar is proven to be as safe and effective as the reference drug. An interchangeable biosimilar has undergone additional FDA testing to show that a patient can switch back and forth with the reference drug without issues. This allows pharmacists to substitute it for the original, per state laws.

Yes. To be approved by the FDA, a biosimilar must demonstrate that it is highly similar to the reference product (Humira) and has no clinically meaningful differences in terms of safety, purity, and potency.

Some of the FDA-approved brand names for adalimumab biosimilars include Amjevita, Cyltezo, Hyrimoz, Hadlima, Abrilada, Simlandi, and Yuflyma.

Biosimilars have the potential to reduce costs, but the actual savings for a patient depend on their health insurance plan, pharmacy benefit manager, and the specific cost-sharing requirements of their coverage.

Citrate is a buffer that was used in the original Humira formulation and could cause pain or a burning sensation during injection. Many new biosimilars, and newer versions of Humira, are 'citrate-free' to reduce injection site pain.

Yes, switching from Humira to a biosimilar is a common practice. Studies have found no difference in safety or effectiveness when switching from Humira to its biosimilars. You should always discuss any medication changes with your healthcare provider.

References

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8
  9. 9
  10. 10
  11. 11
  12. 12
  13. 13
  14. 14
  15. 15
  16. 16

Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.