FDA Expands Adalimumab-Aaty For Pediatrics, Adolescents With Rare Inflammatory Conditions

Celltrion announced expanded FDA indications for adalimumab-aaty (Yuflyma; Celltrion, Inc.) and its unbranded version, including the treatment of adolescents aged 12 and older with hidradenitis suppurativa (HS) and pediatric patients aged 2 and older with uveitis (UV), according to a news release from the company.¹

Adalimumab-aaty has been approved as a biosimilar to adalimumab (Humira; AbbVie) for numerous other conditions, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), Crohn's disease (CD), ulcerative colitis (UC), and plaque psoriasis (Ps). This latest approval expands the previous adult-only indications for HS and UV to include these younger populations, who face high burdens from these conditions.¹

"Adolescent HS and pediatric UV are chronic inflammatory conditions that can have serious sequelae and place a significant burden on patients, their families, and caregivers. It impacts patients physically and also emotionally and socially," Juby Jacob-Nara, senior vice president and chief medical officer at Celltrion, said in the news release. “With this label expansion, [adalimumab-aaty] is now able to provide treatment options for more patient populations, further supporting broader access for both patients and physicians.”¹

What is Hidradenitis Suppurativa?

HS is a condition that induces painful, returning boils near sweat glands on the body. HS can cause a variety of skin growths, including nodules, abscesses, and sinus tracts. Common areas where boils may form include the armpits, genitals, inner thighs, nape of your neck, or waist.²

If HS is left untreated, patients face a heightened risk of developing anemia, cellulitis, scars, sepsis, and damage to your body’s lymphatic system. Although it impacts only 1% to 4% of individuals in the United States, its chronic nature necessitates the development of novel treatment options. For adolescents impacted by the condition, daily life—especially school attendance—is often impacted.^1,2

What is Uveitis?

Though they both are characterized by chronic inflammation UV differs from HS in that it impacts the eyes rather than the skin. Patients with UV harbor inflammation of the uvea, which includes the iris, ciliary body, and choroid.^1,3

It’s more common than HS in pediatrics, accounting for 5% to 10% of all UV cases in the US. The danger in pediatric cases lies with its often-asymptomatic nature; without knowledge of the condition, it can become chronic or lead to major long-term morbidities, including cataract, glaucoma, and amblyopia.^1,3

What is Adalimumab-Aaty?

Adalimumab-aaty is a high-concentration, low-volume, citrate-free biosimilar to adalimumab. It was designed as a recombinant, fully human, anti-tumor necrosis factor α (anti-TNFα) monoclonal antibody. There have been multiple biosimilars approved for adalimumab since 2016, including Amjevita, Cyltezo, Hyrimoz, Hadlima, Abrilada, Hulio, Yusimry, Idacio, and Simlandi.^1,4

Multiple prefilled syringes and autoinjector options are available for adalimumab-aaty. The prefilled syringe is available in doses of 20 mg/0.2 mL, 40 mg/0.4 mL, and 80 mg/0.8 mL; the autoinjector is available in doses of 40 mg/0.4 mL and 80 mg/0.8 mL. Pharmacists should thoroughly discuss these options with patients and decide which dose would be best for their condition.¹

This biosimilar, like its reference product, carries a risk of serious infections, especially if patients are taking concomitant immunosuppressants like corticosteroids. Infections reported in adalimumab-aaty clinical trials included active tuberculosis, invasive fungal infections, and bacterial infections like listeria. Patients prescribed adalimumab-aaty should be extensively monitored and required to report for follow-up visits to their primary care physician.¹

Pharmacists stand to play a critical role in disseminating information to parents and caregivers about these new indications. For patients with these conditions, a new biosimilar provides a low-cost, safe, and effective option, one that could transform their daily lives.

REFERENCES

1. FDA approves expanded pediatric indications for YUMFLYMA (adalimumab-aaty) and unbranded adalimumab-aaty in the United States. Celltrion. News Release. Released October 17, 2025. Accessed October 17, 2025. https://www.prnewswire.com/news-releases/fda-approves-expanded-pediatric-indications-for-yuflyma-adalimumab-aaty-and-unbranded-adalimumab-aaty-in-the-united-states-302587319.html

Hidradenitis suppurativa. Cleveland Clinic. Last Updated December 20, 2022. Accessed October 17, 2025. https://my.clevelandclinic.org/health/diseases/17716-hidradenitis-suppurativa

3. Uveitis. Cleveland Clinic. Last Updated March 25, 2024. Accessed October 17, 2025. https://my.clevelandclinic.org/health/diseases/14414-uveitis

4. Billingsley A. Is there a biosimilar for Humira? Yes, here are 10 Humira biosimilars to choose from. GoodRx. Updated May 14, 2024. Accessed October 17, 2025. https://www.goodrx.com/humira/biosimilars?srsltid=AfmBOoqTJNituNay1M5GOrJuhM-pzL8u2NYQFrRpuwW6tECFggp5SJZI