New Data Support Hulio as an Interchangeable Adalimumab Option

The FDA’s decision to grant an interchangeable biosimilar designation to adalimumab-fkjp, marketed as Hulio, will be driven by compelling evidence from a pivotal clinical study that demonstrated the product’s equivalence to the reference biologic, the data from which were published in Advances in Therapy.¹

The authors conducted the study to fulfill FDA requirements for adalimumab-fkjp (Hulio) to be deemed interchangeable with Humira. | Image credit: Prostock-studio - stock.adobe.com

Interchangeability designations allow pharmacists to substitute a qualifying biosimilar for reference adalimumab (Humira) without prescriber intervention, allowing for easier and quicker access to biologic medicines that are a lower price and covered by the patient’s payer plan.

“The results of this study support the interchangeability status recently granted by FDA for adalimumab-fkjp in order to be used interchangeably with reference adalimumab for chronic plaque psoriasis and other indications,” the authors surmised.

Hulio launched on the US market in 2023, along with 9 other adalimumab biosimilars.² Together, with the launch of (Selarsdi) in 2024,³ the adalimumab market has greatly expanded, with several options having interchangeability designations.² With the exception of insulin biosimilars and biosimilars administered intravitreally, all biosimilars in the US must have data from switching studies to be declared interchangeable.

The randomized, double-blind, parallel-group trial enrolled 386 patients with moderate to severe plaque psoriasis.¹ All participants initially received reference adalimumab. Those who achieved a 50% improvement in the Psoriasis Area and Severity Index (PASI-50 response) were then randomized to either continue treatment with the originator drug or undergo 3 switches between reference adalimumab and the biosimilar Hulio. The study aimed to determine whether repeated switching impacted pharmacokinetics (PK), efficacy, safety, or immunogenicity.

Strong Pharmacokinetic Similarity

The study’s primary end point was to evaluate steady-state PK between the switch and nonswitch groups. Results showed that the 90% CIs for key PK parameters—area under the concentration-time curve at 104.76% and maximum observed concentration at 104.23%—were well within the FDA's accepted bioequivalence range of 80% to 125%. The minimum observed concentration also fell within this range at 107.85%.

“Our data clearly indicated that exposure to both products remained similar, regardless of switching,” noted one of the study authors, emphasizing the reliability of Hulio’s PK profile even in switching scenarios.

Efficacy and Safety Remain Consistent Despite Switching

Efficacy outcomes remained comparable across treatment arms. At week 28, the percentage of patients achieving “clear” or “almost clear” skin on the static Physician’s Global Assessment was 84.3% in the continuous reference adalimumab group and 84.15% in the switching group. Similarly, PASI response levels—PASI-50, PASI-75, PASI-90, and PASI-100—were highly consistent between the 2 arms.

Safety findings further reinforced the case for interchangeability. Treatment-emergent adverse events (TEAEs) were reported by 34.2% of patients in the nonswitch arm and 29.8% in the switch arm. Serious TEAEs were rare and occurred at nearly identical rates: 1.6% in the nonswitch group and 1.7% in the switch group. Discontinuations due to TEAEs were low in both groups (1.0% and 0.6%, respectively).

The study also monitored immunogenicity, assessing the development of antidrug antibodies. These results were consistent across both arms, indicating that multiple switches between biosimilar and reference product did not heighten immune system reactions.

Implications for Managed Care and Biosimilar Adoption

The study’s design—utilizing a homogeneous population treated with monotherapy—ensured clear, interpretable data. By meeting stringent FDA criteria, the study confirmed that switching between Hulio and reference adalimumab does not compromise patient safety or treatment effectiveness.

“Achieving interchangeable status is a crucial step for increasing patient access to biosimilars,” a study author commented. Pharmacist-level substitution can reduce prescribing barriers, improve affordability, and ease integration into managed care formularies.

Hulio’s new designation represents a significant advancement in the broader adoption of biosimilars in the US. The findings highlight the scientific rigor required to demonstrate interchangeability while also supporting cost savings, competitive markets, and expanded treatment access for patients relying on high-cost biologic therapies.

References

1. Deodhar S, Longanathan S, Reddy RKS, et al. Multiple switches between adalimumab-fkjp and reference adalimumab in moderate-to-severe chronic plaque psoriasis: a multicenter, double-blind, parallel-group, randomized clinical trial for interchangeability. Adv Ther. Published online June 10, 2025. doi:10.1007/s12325-025-03240-5

2. Jeremias S. Happy birthday adalimumab biosimilars: reflecting on the first year of US competition. The Center for Biosimilars^®. January 31, 2024. Accessed June 16, 2025. https://www.centerforbiosimilars.com/view/happy-birthday-adalimumab-biosimilars-reflecting-on-the-first-year-of-us-competition

3. Jeremias S. Eye on pharma: Simlandi US launch; ranibizumab partnership; expanded access for adalimumab biosimilars. The Center for Biosimilars. May 27, 2024. Accessed June 16, 2025. https://www.centerforbiosimilars.com/view/eye-on-pharma-simlandi-us-launch-ranibizumab-partnership-expanded-access-for-adalimumab-biosimilars