Humira Biosimilar Boom: 9 Meds Coming in 2023 and Beyond - GoodRx (2024)

If you take Humira (adalimumab), you may be wondering when a generic version is 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. And now, 20 years after Humira launched, the first nine Humira biosimilars are expected to become available in the U.S. in 2023.

What is Humira?

Humira is an injectable tumor necrosis factor (TNF) blocker. It works by blocking a protein called TNF, which causes inflammation in the body. Humira is approved to treat several autoimmune conditions in adults and children, including the following:

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.

Humira vs. Humira biosimilars

The Humira biosimilars launching in 2023 are approved for most of the same uses as Humira, with two exceptions. Some of the biosimilars are approved to treat hidradenitis suppurativa (HS), but not all of them. And they’re only approved for this use in adults. None of the biosimilars are approved to treat uveitis. They vary in their available concentrations and doses as well.

When Humira products were first introduced, they used a formulation that had a relatively low concentration 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 a higher concentration, 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.

1. Amjevita

Amjevita (adalimumab-atto) became the first FDA-approved Humira biosimilar in September 2016. On January 31, 2023, it was also the first Humira biosimilar to launch in the U.S.

Amjevita is one of the Humira biosimilars approved to treat HS in adults. It’s currently available in prefilled autoinjector pens (40 mg) and prefilled syringes (10 mg, 20 mg, 40 mg). Amjevita products come in low-concentration, citrate-free forms.

2. Cyltezo

Cyltezo (adalimumab-adbm) 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. It’s also a Humira biosimilar approved to treat HS in adults.

Interchangeable biosimilars go through additional studies to determine whether you can 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 your state, your pharmacist may be able to dispense Cyltezo for a Humira prescription without contacting your healthcare provider. Think of it as substituting a generic for a brand-name medication. Other Humira biosimilars can’t be substituted this way.

Cyltezo is currently approved as a prefilled pen (40 mg) and syringe (10 mg, 20 mg, and 40 mg). All are low-concentration forms and citrate-free.

Cyltezo launched on July 1, 2023, making it the first interchangeable Humira biosimilar available in the U.S.

3. Hyrimoz

In October 2018, Hyrimoz (adalimumab-adaz) became the third FDA-approved Humira biosimilar. Hyrimoz is also approved to treat HS in adults. It will be available in the following doses and forms:

• Injection pen: 40 mg (low-concentration); 40 mg and 80 mg (high-concentration)

• Prefilled syringe: 10 mg, 20 mg, 40 mg (low-concentration); 10 mg, 20 mg, 40 mg, 80 mg (high-concentration)

The lower-concentration doses contain citric acid, which is closely related to citrate. Citric acid can also make injections more painful. The high-concentration doses are citrate-free.

The high concentration, citrate-free versions of Hyrimoz launched in the U.S. on July 1, 2023.

4. Hadlima

Hadlima (adalimumab-bwwd) became the fourth FDA-approved Humira biosimilar in July 2019. Hadlima officially launched in the U.S. on July 1, 2023.

Hadlima is available in both an autoinjector and a syringe in a 40 mg dose. And it will come in both low- and high-concentration forms. The high-concentration form is citrate-free. A low-concentration vial is available for use in healthcare facilities.

5. Abrilada

Abrilada (adalimumab-afzb) became the fifth FDA-approved Humira biosimilar in November 2019. It will be available in a prefilled pen (40 mg) and in a syringe (10 mg, 20 mg, 40 mg). All Abrilada products will be low-concentration forms and citrate-free. A vial will be available for use in healthcare facilities.

Abrilada’s manufacturer has applied for interchangeable status with Humira, looking to follow in Cyltezo’s footsteps. If approved, your pharmacist may be allowed to substitute Abrilada for Humira.

Abrilada is expected to launch in the U.S. in the second half of2023.

6. Hulio

Hulio (adalimumab-fkjp) became the sixth FDA-approved Humira biosimilar in July 2020. Hulio is also approved to treat HS in adults. It’s available in a prefilled pen (40 mg) and in a syringe (20 mg and 40 mg). All forms are low-concentration and citrate-free.

Hulio launched in the U.S. in early July 2023.

7. Yusimry

Yusimry (adalimumab-aqvh) became the seventh FDA-approved Humira biosimilar in December 2021. Yusimry is also approved to treat HS in adults. It’s only available in a low concentration and citrate-free 40 mg prefilled pen and syringe.

Yusimry launched in the U.S. in early July 2023.

8. Idacio

Idacio (adalimumab-aacf) became the eighth FDA-approved Humira biosimilar in December 2022. Idacio officially launched in the U.S. in early July 2023.

Idacio is available in a 40 mg dose in both a pen and a syringe. Both forms will be low-concentration and citrate-free.

9. Yuflyma

Yuflyma (adalimumab-aaty) is the ninth and most recent FDA-approved Humira biosimilar. It was approved in late May 2023. Yuflyma is also approved to treat HS in adults.

Yuflyma is available in a 40 mg dose in both a prefilled syringe and autoinjector. Both forms 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.

How to choose the best Humira biosimilar

So, should you switch to a Humira biosimilar? It depends. There are a few things to consider when discussing your options with your healthcare provider.

• Why you’re taking it. If you’re taking Humira for HS, certain biosimilars also have this indication. But if you’re taking Humira for uveitis, you may need to stick with it for now. No Humira biosimilars are currently approved for this condition.

• Dosage. If you’re taking 40 mg, you’ll have several options to choose from. Your options may be more limited if you need a different dosage.

• Ingredients. Most Humira biosimilars don’t contain citrate. If you’re currently taking a citrate-free Humira product (or you’re looking to switch to one), you may have several options.

• Concentration. If you’re currently taking a high-concentration Humira product, Hadlima, Yuflyma, or Hyrimoz may be an option, depending on the dosage you need. For now, all other Humira biosimilars will only be available in low-concentration forms.

• 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 first.

• Ways to save. Manufacturer copay cards may be available for biosimilars. They can help make your prescription more affordable. If you’re uninsured or underinsured, you may be eligible for a patient assistance program.

Your healthcare provider can help you navigate your options. Keep in mind that additional Humira biosimilars may hit the market in 2023 and beyond.