Key takeaways:
Humira (adalimumab) is an injectable medication used to treat several autoimmune conditions. It has been available as a brand-name medication in the U.S. since 2002.
Since 2016, 10 Humira biosimilars have been approved in the U.S. These medications are highly similar to Humira. Several are considered interchangeable with Humira. The first Humira biosimilar launched in January 2023.
Humira biosimilars have varying doses, dosage forms, and concentrations. In some cases, they also have different approved uses. Your healthcare team can help you decide which biosimilar might be right for you.
If you’re prescribed Humira (adalimumab), you may have wondered when a generic version was going to be available. But Humira isn’t like most medications found on pharmacy shelves. It’s a biologic, meaning it comes from living sources, like animal or plant cells.
Biologics don’t have generics. Instead, they have biosimilars. These are lower-cost medications that are highly similar to the original (reference) medication.
Now, more than 20 years after the original medication first launched, 10 Humira biosimilars have been approved.
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Humira is an injectable tumor necrosis factor (TNF) blocker. This means it works by blocking the protein TNF, which causes inflammation in the body. Humira is approved to treat several autoimmune conditions in adults and children, including those listed in the chart below.
Approved uses for adults only | Approved uses for children and adults |
• Rheumatoid arthritis (RA) | • Juvenile idiopathic arthritis for ages 2 and older |
Humira is packaged in three different ways: a prefilled pen, a prefilled syringe, and a vial. It also comes in several different doses, ranging from 10 mg to 80 mg. Humira is usually administered once a week or once every other week.
There are a few differences between Humira and the approved Humira biosimilars. First, not all of the biosimilars are approved to treat HS and uveitis. And the ones that are are only approved for HS and uveitis in adults, not children. The biosimilars also have varying concentrations and doses.
When Humira products were first introduced, they used a formulation that had a relatively low concentration of the active ingredient and contained citrate, an ingredient that can make injections more painful. These products are still available, and most of the biosimilars are based on this original, low-concentration formula. But many of them don’t contain citrate.
Newer Humira products are citrate-free and come in higher concentrations, so they deliver the same amount of medication in a smaller amount of liquid. This may make injections easier and faster. A few biosimilars have high-concentration forms approved or under FDA review.
The chart below summarizes all of the FDA-approved Humira biosimilars. In the following sections, we’ll review each of these biosimilars in detail.
Humira biosimilar | Approval date | Forms, doses, and concentrations |
Amjevita | Autoinjector pens: 40 mg (low concentration); 40 mg, 80 mg (high concentration) All doses are citrate-free. | |
Cyltezo*(adalimumab-adbm) | Prefilled pen: 40 mg (low and high concentration) All doses are citrate free. | |
Hyrimoz | Prefilled pens: 40 mg (low concentration); 40 mg, 80 mg (high concentration) High-concentration doses are citrate-free. | |
Hadlima | Autoinjector pen: 40 mg (low and high concentration) High-concentration doses are citrate-free. | |
Abrilada*(adalimumab-afzb) | Prefilled pen: 40 mg All doses are low concentration and citrate-free. | |
Hulio | Prefilled pen: 40 mg All doses are low concentration and citrate-free. | |
Yusimry | Prefilled pen: 40 m mg All doses are low concentration and citrate-free. | |
Idacio | Prefilled pen: 40 mg All doses are low concentration and citrate free. | |
Yuflyma | Autoinjector pens: 40 mg, 80 mg All doses are high concentration and citrate-free. | |
Simlandi* | February 2024 | Autoinjector pen: 40 mg (high concentration, citrate-free) |
*Interchangeable biosimilar to Humira
Making the switch: Thinking about switching to a Humira biosimilar? Here are five questions to ask your pharmacist to see if a biosimilar is right for you.
Knowing the difference: Experts discuss the key differences between biosimilars and generics, and when you might be prescribed one instead of the other.
How to save: Biosimilars can help you save money at the pharmacy. Learn more about ways to save on biosimilars with copay cards, rebates, and more.
Amjevita became the first FDA-approved Humira biosimilar in September 2016. And, on January 31, 2023, it became the first Humira biosimilar to launch in the U.S.
Amjevita is one of the Humira biosimilars approved to treat HS and uveitis in adults. It’s currently available in prefilled autoinjector pens (40 mg and 80 mg) and prefilled syringes (10 mg, 20 mg, 40 mg, and 80 mg). Amjevita products come in both high- and low-concentration, citrate-free forms.
Cyltezo became the second FDA-approved Humira biosimilar in August 2017. In October 2021, it also became the first biosimilar to be designated as interchangeable with Humira. And it launched on July 1, 2023. Like Amjevita, it’s approved to treat HS and uveitis in adults.
Interchangeable biosimilars have gone through additional studies to determine that it’s possible to switch back and forth between the biosimilar and the original product without issues. Biosimilars without this designation haven’t gone through these same studies.
But what does this mean for people taking these medications? Depending on the state you live in, your pharmacist may be able to dispense Cyltezo in place of Humira without contacting your prescriber. Think of it as substituting a generic for a brand-name medication. Not all Humira biosimilars can be substituted in this way.
Cyltezo is currently available as a prefilled pen (40 mg) and syringes (10 mg, 20 mg, and 40 mg). The 40 mg doses are available in both low-concentration and high-concentration forms. The rest of the doses are low concentration only. All forms are citrate free.
Cyltezo is also available as an unbranded product called adalimumab-adbm. The unbranded product is the same as Cyltezo, but without the Cyltezo brand name. It comes in the same doses and dosage forms as Cyltezo and is interchangeable with Humira. Anyone with a valid prescription, regardless of insurance status, can use GoodRx to purchase two adalimumab-adbm pens at an exclusive cash price of $550.
In October 2018, Hyrimoz became the third FDA-approved Humira biosimilar. Hyrimoz is also approved to treat HS in adults. It’s available in the following doses and forms:
Injection pens: 40 mg (low concentration); 40 mg and 80 mg (high concentration)
Prefilled syringes: 10 mg, 20 mg, and 40 mg (low concentration); 10 mg, 20 mg, 40 mg, and 80 mg (high concentration)
The low-concentration forms contain citric acid, which is closely related to citrate. Citric acid can also make injections more painful. The high-concentration forms are citrate-free.
The high-concentration, citrate-free versions of Hyrimoz launched in the U.S. on July 1, 2023.
Hadlima became the fourth FDA-approved Humira biosimilar in July 2019. Hadlima officially launched in the U.S. on July 1, 2023. In addition to other Humira indications, it’s approved to treat HS and uveitis in adults.
Hadlima is available in both an autoinjector and a syringe in a 40 mg dose. Both low- and high-concentration forms are available. The high-concentration forms are citrate-free. A low-concentration vial is available for use in healthcare facilities.
Abrilada became the fifth FDA-approved Humira biosimilar in November 2019. It was also the second interchangeable Humira biosimilar to be approved. Abrilada officially launched in late November 2023. And like Humira, it’s approved to treat HS and uveitis in adults.
Abrilada is available in a prefilled pen (40 mg) and syringes (10 mg, 20 mg, and 40 mg). All Abrilada products are low concentration and citrate-free. A vial is available for use in healthcare facilities.
Hulio became the sixth FDA-approved Humira biosimilar in July 2020. And it launched in the U.S. in early July 2023.
Hulio is also approved to treat HS and uveitis in adults. It’s available in a prefilled pen (40 mg) and syringes (20 mg and 40 mg). All forms are low concentration and citrate-free.
Yusimry became the seventh FDA-approved Humira biosimilar in December 2021. And it also launched in the U.S. in early July 2023.
Yusimry is also approved to treat HS and uveitis in adults. It’s only available in a low-concentration and citrate-free 40 mg prefilled pen and syringe.
Idacio became the eighth FDA-approved Humira biosimilar in December 2022. Idacio officially launched in the U.S. in early July 2023. It’s not currently approved to treat HS or uveitis.
Idacio is available in a 40 mg dose prefilled pen and syringe. Both forms are low concentration and citrate-free.
Yuflyma became the ninth FDA-approved Humira biosimilar in late May 2023. Yuflyma is also approved to treat HS and uveitis in adults.
Yuflyma is available in prefilled syringes (20 mg, 40 mg, and 80 mg) and autoinjectors (40 mg and 80 mg). All products are high concentration and citrate-free.
Yuflyma launched in the U.S. in early July 2023. Its manufacturer is hoping that Yuflyma will be approved as an interchangeable biosimilar by the end of 2024.
Simlandi became the 10th FDA-approved Humira biosimilar in February 2024. It’s the first high-concentration and citrate-free interchangeable Humira biosimilar. And like most biosimilars on this list, it’s approved to treat HS and uveitis in adults. Simlandi comes as a 40 mg autoinjector.
So, should you switch to a Humira biosimilar? It depends. There are a few things to consider when discussing your options with your prescriber:
Why you’re taking it: If you’re taking Humira for HS or uveitis, most biosimilars also have these indications for adults. But there are some that do not.
Your dosage: If you’re taking 40 mg of Humira, you’ll have many options to choose from. Your options may be more limited if you need a different dosage.
The ingredients: If you’re currently taking a citrate-free Humira product (or you’re looking to switch to one), you’ll have several options. Most Humira biosimilars don’t contain citrate.
The concentration: If you’re currently taking a high-concentration Humira product, you have a few biosimilar options, depending on the dosage you need.
Your insurance coverage: Your insurance plan may offer better coverage for Humira than for biosimilars. Or it may prefer certain Humira biosimilars over others. If you’re thinking about switching your medication and have health insurance, it’s a good idea to check with your plan about coverage first.
Ways to save: Manufacturer copay cards may be available for some of the biosimilars. This could help make your prescription more affordable. If you’re uninsured or underinsured, you may be eligible for a patient assistance program.
Keep in mind that additional Humira biosimilars may hit the market in 2024 and beyond. Your prescriber can help you navigate your options now and in the future.Â
Since 2016, 10 Humira (adalimumab) biosimilars have been approved in the U.S. The first biosimilar launched in January 2023. Humira biosimilars are approved to treat many of the same medical conditions as Humira. But they have varying dosages and concentrations.
Talk to your healthcare team if you’re interested in switching to a Humira biosimilar. It’s also a good idea to check with your insurance plan before switching medications. GoodRx can also help you navigate ways to save on Humira biosimilars.
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