Key takeaways
Humira (adalimumab) is a tumor necrosis factor blocker (TNF blocker) used for various autoimmune inflammatory conditions such as the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and others.
Because Humira is classified as a biologic, highly similar versions are called biosimilars (rather than generics).
Some biosimilars, including Humira, are interchangeable, which means a pharmacist can fill a prescription for the drug using an interchangeable biosimilar instead of Humira if state law allows it.
Talk to your healthcare provider for more information about Humira biosimilars and which treatment is best for you.
Humira is a prescription injectable drug. It is given by subcutaneous injection under the skin of the stomach or thigh. It is used to treat various autoimmune inflammatory diseases, including:
- Rheumatoid arthritis (RA) in adults
- Polyarticular juvenile idiopathic arthritis (JIA) in children ages 2 and older
- Psoriatic arthritis in adults
- Ankylosing spondylitis in adults
- Hidradenitis suppurativa (HS) in adults and adolescents ages 12 and older
- Crohn’s disease in adults and children ages 6 and older
- Ulcerative colitis (UC) in adults and pediatric patients ages 5 and older
- Plaque psoriasis in adults
- Non-infectious uveitis in adults and children ages 2 and older
Humira is a biologic drug and is also known as a monoclonal antibody. Biologics come from natural sources and may be produced using biotechnology. While nonbiologic drugs are made with chemicals and have a known structure, most biologics are complex mixtures and cannot be easily identified or characterized, according to the Food & Drug Administration (FDA).
Humira is classified as a tumor necrosis factor (TNF) blocker. It works by blocking the effects of TNF, a cytokine (chemical messenger) that causes inflammation.
Since brand-name medications can be expensive, patients often ask about generic versions. However, because Humira is a biologic, it does not have a generic version. Instead, it has biosimilar versions. Continue reading to learn more about FDA approved Humira biosimilars, which are made by various drug companies.
Low-cost FDA approved Humira biosimilars
We refer to prescription and over-the-counter (OTC) drugs as brand and generic drugs. For example, your healthcare provider may write a prescription for Lipitor to treat high cholesterol, and your pharmacist may dispense atorvastatin, the generic version of Lipitor.
However, when discussing biologics, the original drug—such as Humira, is called a reference product.
A biosimilar is a nearly identical copy of the approved biologic drug. Because they are complex, a biosimilar cannot be exactly the same. However, they contain the same ingredient, work the same way, and have the same mode of administration (such as injection) and dosing as the reference product. Biosimilars are clinically tested to ensure they are as safe and effective as the original medication. They’re reviewed and approved by the FDA and undergo ongoing monitoring.
Interchangeability is an FDA designation that means the biosimilar can be substituted (considered interchangeable) for the reference product (in this case, Humira). Like the Lipitor example above, if a Humira biosimilar has an interchangeability designation, that specific biosimilar can be dispensed in place of Humira if allowed by state law. However, not all biosimilars are interchangeable. We’ll go more into this below, as we review the approved biosimilars.
Note that the active ingredient in Humira is called adalimumab. The biosimilars are also called adalimumab, but they have a four-letter suffix after the name. These letters are used to differentiate biosimilars from the original reference product. If the letters may seem random, that’s because the FDA has some guidelines for these suffixes, including that they have four unique lowercase letters that do not have any meaning. For example, if Teva makes a biosimilar, the last four letters cannot be -teva.
Continue reading to learn about the ten approved Humira biosimilars.
Amjevita (adalimumab-atto)
Amjevita was the first Humira biosimilar to be approved. It was FDA approved in 2016 and became available in the United States in January 2023. The pharmaceutical company that makes Amjevita is called Amgen, Inc.
Amjevita has the same uses as Humira, except it can only be used in adult patients for HS, UC, and uveitis. Athough it is biosimilar to Humira, it is not interchangeable. This means that if a healthcare provider writes a prescription for Humira, the pharmacist will not dispense Amjevita. The healthcare provider must write the prescription for Amjevita for you to receive Amjevita.
Humira has a newer, citrate-free formulation—which causes less pain when injected. Amjevita is also citrate-free.
Cyltezo (adalimumab-adbm)
Cyltezo was the second biosimilar and first interchangeable Humira biosimilar to be approved. It was FDA approved in August 2017 as a biosimilar, approved in 2021 as an interchangeable biosimilar, and became available in the United States in July of 2023. The pharmaceutical company that makes Cyltezo is called Boehringer Ingelheim Pharmaceuticals, Inc.
Because Cyltezo is an interchangeable biosimilar, this means that if a doctor writes a prescription for Humira, the pharmacist may dispense Cyltezo, if allowed by state law.
Cyltezo has the same uses as Humira, except it can only be used in adults for HS, UC, and uveitis. Cyltezo is citrate-free.
RELATED: Cyltezo vs. Humira
Hyrimoz (adalimumab-adaz)
Hyrimoz was the third Humira biosimilar, approved in October 2018 and available in the United States in July 2023. The pharmaceutical company that makes Hyrimoz is called Cordavis Limited.
Hyrimoz has many of the same approved uses as Humira but is only approved for UC in adults. It is not approved for HS or uveitis. The biosimilar is citrate-free. Additionally, it has a higher concentration than Humira, which means the same amount of medicine is delivered in less liquid, making injections faster and easier.
Hadlima (adalimumab-bwwd)
Hadlima was the fourth Humira biosimilar, approved in July 2019 and available in the United States as of July 2023. Hadlima was also approved as an interchangeable biosimilar by the FDA in November 2023. The pharmaceutical company that makes Hadlima is called Organon.
Hadlima has the same approved uses as Humira, but it is only approved for UC, HS, and uveitis in adults. Hadlima is available in a high-concentration citrate-free formulation. It is also available in a low-concentration formulation that is not citrate-free.
Abrilada (adalimumab-afzb)
Abrilada was the fifth Humira biosimilar approved by the FDA. It was approved in November 2019 as a biosimilar and approved as an interchangeable biosimilar in October 2023. Pfizer is the manufacturer of Abrilada.
Abrilada has the same approved uses as Humira but is only approved for UC, HS, and uveitis in adults. It is available in a low-concentration citrate-free formulation.
Hulio (adalimumab-fkjp)
Hulio was approved by the FDA in July 2020 and became available in the United States in July 2023. Biocon Biologics makes this biosimilar. It is a citrate-free, low-concentration formulation.
Hulio has the same uses as Humira, except it can only be used in adults for HS, UC, and uveitis.
Yusimry (adalimumab-aqvh)
Yusimry was FDA approved in December 2021 and became available in the United States in July 2023. Yusimry is made by the drug company Coherus BioSciences, Inc. This biosimilar is available in a citrate-free formulation.
Yusimry has the same uses as Humira but can only be used in adults for UC, HS, and uveitis.
Idacio (adalimumab-aacf)
Idacio was FDA approved in December 2022 and became available in the United States in July 2023. The pharmaceutical company that makes Idacio is Fresenius Kabi. Idacio is a citrate-free, low-concentration formulation of adalimumab.
Idacio is not approved for HS or uveitis. For ulcerative colitis, it is only FDA approved for adults.
Yuflyma (adalimumab-aaty)
Yuflyma was approved by the FDA in May 2023 and is available in the United States as of July 2023. Made by Celltrion USA, Yuflyma is a high-concentration, citrate-free formulation.
This biosimilar has the same uses as Humira but can only be used in adults for UC, HS, and uveitis.
Simlandi (adalimumab-ryvk)
In February 2024, the pharmaceutical company Alvotech received FDA approval for its biosimilar, Simlandi. This is the tenth biosimilar for Humira. Simlandi is also approved as an interchangeable biosimilar.
Simlandi is approved for the same uses as Humira but only for UC, HS, and uveitis in adults. Simlandi is available as a high-concentration and citrate-free formulation.
Humira and biosimilar warnings
Because Humira and its biosimilars contain the same active ingredient, adalimumab, they have the same warnings.
These drugs have a boxed warning, the most serious warning required by the FDA. The warning states that because adalimumab products affect the immune system, there is an increased risk of serious infections that can lead to hospitalization or death. Adalimumab may also increase the risk of lymphoma and other types of cancers.
Other serious side effects may occur, including serious allergic reactions, reactivation of the hepatitis B virus, heart failure, low blood cell counts, lupus-like syndrome, and others.
This is not a full list of warnings. Consult your healthcare provider for more information about Humira warnings.
How to choose the best Humira biosimilar
Although the various options may seem overwhelming, your healthcare provider can work with you to find the best option for your unique health conditions and concerns. There are various individual factors to consider, such as the condition you are treating, the available formulations, dosage, and other factors. Consult your healthcare provider for medical advice on the best Humira biosimilar for you.
RELATED: Humira cost savings and tips
Sources
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- Biosimilars: What you should know, Crohn’s & Colitis Foundation
- Interchangeable biological products, U.S. Food & Drug Administration
- Alphabet soup: The story behind biosimilar nonproprietary name suffixes, AJMC The Center For Biosimilars (2020)
- AmjevitaTM (adalimumab-atto), first biosimilar to Humira, now available in the
United States, Amgen Press Release (2023) - Humira Citrate-free?, Humira
- Cyltezo®, first and only FDA approved interchangeable biosimilar to Humira®, now commercially available in the U.S., Boehringer Ingelheim (2023)
- Biosimilar product information, U.S. Food & Drug Administration (2024)
- Sandoz to launch Hyrimoz ® (adalimumab-adaz) high-concentration formulation, marking Sandoz entrance into US immunology space, Novartis (2023)
- Organon & Samsung Bioepis announce US launch of Humira biosimilar HadlimaTM (adalimumab-bwwd) in multiple presentations consistent with originator, Organon (2023)
- Samsung Bioepis & Organon announce FDA acceptance of supplemental biologics license application (sBLA) for interchangeability designation for HadlimaTM (adalimumab-bwwd), a biosimilar to Humira®, Organon (2023)
- FDA grants interchangeable designation to Pfizer’s biosimilar AbriladaTM, Pfizer (2023)
- Abrilada approved as second interchangeable Humira biosimilar, AJMC The Center for Biosimilars (2023)
- U.S. welcomes Idacio, Hulio to the adalimumab biosimilar market, AJMC The Center for Biosimilars (2023)
- Coherus launches YusimryTM, a biosimilar of Humira®, at $995 per carton in U.S., Coherus (2023)
- Celltrion launches Yuflyma on the US market, AJMC The Center For Biosimilars (2023)
- FDA approves 10th adalimumab biosimilar, Simlandi, AJMC The Center for Biosimilars (2024)
- Alvotech and Teva announce U.S. approval of Simlandi® (adalimumab-ryvk) injection, the first interchangeable high-concentration citrate-free biosimilar to Humira®, Alvotech (2024)
- Humira, National Library of Medicine DailyMed (2024)