Since 2016, the FDA has approved 10 biosimilars for Humira in the US. These biosimilars closely resemble Humira, with some even being deemed interchangeable.
One of the most significant benefits of Humira biosimilars is the potential for cost savings. According to a 2017 RAND report, biosimilars could save the US healthcare system $54 billion on biologic drug costs between 2017 and 2026.
This increased affordability opens up access to a wider range of patients, especially those who face challenges with the high cost of biologic treatments. In this article, we’ll explore the approved biosimilar products and their benefits.
Selecting the Right Humira Biosimilar
When selecting a biosimilar to Humira, consider the following factors:
- FDA Approval and Interchangeability Status: Check if the biosimilar is FDA-approved and whether it has interchangeable status. Interchangeable biosimilars can be substituted for Humira at the pharmacy without needing approval from your doctor.
- Concentration and Formulation: Biosimilars come in different formulations, including high-concentration and citrate-free versions. High-concentration formulations require less volume per injection, and citrate-free options may reduce injection-site pain.
- Clinical Trial Data: Review the clinical trial data comparing the biosimilar to Humira. Look for evidence that shows similar efficacy, safety, and immunogenicity.
- Cost and Insurance Coverage: Consider the cost of the biosimilar and your insurance coverage. Some biosimilars may be more affordable, depending on your insurance plan.
- Patient Support Programs: Check if the manufacturer offers patient support programs that provide financial assistance and resources to help manage your treatment.
- Physician Recommendation: Consult with your healthcare provider for their recommendation based on your medical needs and treatment goals.
Choose a Humira biosimilar that meets your needs and provides effective treatment.
List of Humira® Biosimilars
Here is a list of all FDA-approved biosimilars of Humira:
Price: Starts at $680 (syringes) and $1400 (autoinjector pens)
Active ingredients: Adalimumab-atto
Dosage form: Syringe and autoinjector pen (Amjevita SureClick)
Dosage frequency: Every other week
Advantages:
Disadvantages:
In early studies, Amjevita showed similar function and pharmacokinetics to Humira. Additionally, it had a similar structure, including properties like purity, carbohydrate makeup, and stability under stress.
Moreover, a 26-week phase III equivalence study showed that both drugs demonstrated similar results across the following measures:
- Levels of improvement (at 20%, 50%, and 70%)
- Disease activity reduction
- Common and serious side effects
- Fatal events
- Immunogenicity
In a follow-up study, patients either continued with Amjevita or switched from Humira to Amjevita. At weeks 48 and 70, response rates remained comparable between the two groups.
Price: Starts at $1400 (syringes) and $1400 (autoinjector pens)
Active ingredients: Adalimumab-bwwd
Dosage form: Syringe and autoinjector pen (Hadlima PushTouch)
Dosage frequency: Every other week
Advantages:
Disadvantages:
A study comparing Hadlima and Humira showed that both drugs were equally effective, with around 72% of patients in each group showing improvement. This effectiveness was consistent even after some patients switched from Humira to Hadlima.
In terms of safety, side effects were similar between the two groups. Around 36% of patients on Hadlima and 41% on Humira experienced some side effects by week 24. Serious adverse effects were rare in both groups, and the rates of these effects remained comparable.
Price: Starts at $729 (syringes) and $1400 (autoinjector pens)
Active ingredients: Adalimumab-fkjp
Dosage form: Syringe and autoinjector pen (Hulio Pen)
Dosage frequency: Every other week
Advantages:
Disadvantages:
Before approval, studies confirmed that Hulio is structurally and functionally similar to Humira. A later phase I trial showed that both medications behaved similarly in the body and had comparable safety profiles in healthy people.
A larger phase III and final phase studies showed that both Hulio and Humira had similar success rates in improving symptoms. Side effects were also similar between both groups. However, Hulio had a slightly higher rate of serious side effects that led to stopping treatment.
Price: Starts at $740 (syringes) and $1479 (autoinjector pens)
Active ingredients: Adalimumab-adaz
Dosage form: Syringe and autoinjector pen (Hyrimoz Sensoready)
Dosage frequency: Every other week
Advantages:
Disadvantages:
During a phase III study, one group received Hyrimoz while the other received Humira. After 24 weeks, the Humira group switched to Hyrimoz until week 46. The results were almost identical between the two groups, with Hyrimoz showing a decrease of 2.16 points in disease activity score and Humira a decrease of 2.18 points.
By week 48, the results remained similar, regardless of whether patients had switched from Humira to Hyrimoz or continued with Hyrimoz from the start. The effectiveness of the treatment, measured by 20%, 50%, and 70% improvement rates, was also consistent between both groups throughout the trial.
Price: Starts at $1400 (autoinjector pens)
Active ingredients: Adalimumab-aacf
Dosage form: Syringe and autoinjector pen (Idacio Pen)
Dosage frequency: Every other week
Advantages:
Disadvantages:
Studies confirmed that Idacio is structurally and functionally similar to Humira, with the same amino acid sequence and protein structure. It also showed lower oxidation levels, which is a positive indicator.
A large phase III trial found that Idacio and Humira are equally effective in treating arthritis symptoms. Although switching between the two hasn’t been tested in rheumatoid arthritis, a study in psoriasis patients showed that switching didn’t impact treatment effectiveness or safety.
Regarding safety, fewer people on Idacio had to discontinue treatment due to side effects (4.2% vs. 9.7%), and serious side effects were less common. Injection site reactions were also less frequent with Idacio. While these differences weren’t significant, they did favor Idacio.
Price: Starts at $1479 (autoinjector pens)
Active ingredients: Adalimumab-aaty
Dosage form: Syringe and autoinjector pen (Yuflyma AI)
Dosage frequency: Every other week
Advantages:
Disadvantages:
Yuflyma became the ninth FDA-approved Humira biosimilar in May 2023 and launched in the US in July 2023. It also hopes to gain interchangeable status by the end of 2024.
Yuflyma’s approval was based on studies showing it’s comparable to Humira. A 2021 phase III study published in Arthritis Research & Therapy found that at week 24, 82.7% of patients with rheumatoid arthritis showed a 20% improvement in both Yuflyma and Humira groups. Additional outcomes and safety were similar.
A switching study further confirmed Yuflyma’s comparable efficacy, safety, and immunogenicity after one year of treatment.
Price: Starts at $740 (syringes) and $1400 (autoinjector pens)
Active ingredients: Adalimumab-afzb
Dosage form: Syringe and autoinjector pen (Abrilada Pen)
Dosage frequency: Every other week
Advantages:
Disadvantages:
The clinical trial results comparing Abrilada and Humira were very close, with 68.7% of patients on Abrilada and 72.7% on Humira achieving 20% symptom improvement. Other measures of effectiveness were also similar between the two treatments throughout the study.
In addition, the rates of side effects were nearly the same between the groups, with around 48% of patients in both experiencing at least one side effect. Even after switching from Humira to Abrilada, the safety profile remained consistent.
Cyltezo
Price: Starts at $550 (syringes) and $1507 (autoinjector pens)
Active ingredients: Adalimumab-adbm
Dosage form: Syringe and autoinjector pen (Cyltezo Pen)
Dosage frequency: Every other week
Advantages:
Disadvantages:
Cyltezo, the second FDA-approved Humira biosimilar, received approval in August 2017 and became the first Humira biosimilar approved with interchangeability status.
In a 58-week clinical trial, 67.0% of patients treated with Cyltezo showed a 20% improvement in rheumatoid arthritis symptoms, compared to 61.1% of those on Humira, demonstrating equivalence between the two treatments. Additional measures of effectiveness were also similar at both 24 and 48 weeks.
Yusimry
Price: Starts at $1247 (autoinjector pens)
Active ingredients: Adalimumab-aqvh
Dosage form: Syringe and autoinjector pen (Yusimry Pen)
Dosage frequency: Every other week
Advantages:
Disadvantages:
Yusimry is closely comparable to Humira, with minor physicochemical differences that do not impact its functional activity. According to researchers, these variations are unlikely to affect the biosimilar’s clinical efficacy or safety.
Simlandi
Price: Starts at $1042 (autoinjector pens)
Active ingredients: Adalimumab-ryvk
Dosage form: Autoinjector pen
Dosage frequency: Every other week
Advantages:
Disadvantages:
The approval of Simlandi marks the introduction of the first high-concentration, citrate-free biosimilar to Humira with interchangeable status. The FDA’s decision was based on comprehensive evidence, including analytical, non-clinical, and clinical data from three studies.
Wrap-Up
Humira biosimilars treat many of the same conditions as Humira, but they may have different dosages and concentrations. Consult your doctor if you’re thinking about switching to a Humira biosimilar. Additional options may become available in 2025 and the following years, and your prescriber can help you make the best choice.
Frequently Asked Questions
Related Articles
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