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INDICATIONS
Rheumatoid Arthritis: HULIO is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HULIO can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
Juvenile Idiopathic Arthritis: HULIO is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. HULIO can be used alone or in combination with methotrexate.
Psoriatic Arthritis: HULIO is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HULIO can be used alone or in combination with non-biologic DMARDs.
Ankylosing Spondylitis: HULIO is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
Crohn’s Disease: HULIO is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
Ulcerative Colitis: HULIO is indicated for the
treatment of moderately to severely active ulcerative colitis in
adult patients.
Limitations of Use:
The effectiveness of adalimumab products has not been
established in patients who have lost response to or were
intolerant to TNF blockers.
Plaque Psoriasis: HULIO is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HULIO should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
Hidradenitis Suppurativa: HULIO is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.
Uveitis: HULIO is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
Enroll Your Patient Today
Download the Hulio360™ Enrollment and Prescription Form
Then fax your completed form to 1-866-335-7539.
Download the FormYou can also e-prescribe your HULIO prescription by searching for The Lash Group in your EHR.* Be sure to include your patient’s mobile number.†
*The Lash Group, 1800 Innovation Pt, Fort Mill, SC 29715; NCPDP; 423942.
†By providing the patient's phone number, you represent that your patient is aware of the disclosure and has given consent to be contacted regarding this prescription, and by the fulfillment pharmacy.
EHR=electronic health record.
The evidence behind Hulio
HULIO has achieved all the benchmarks for biosimilarity to Humira.
The totality of evidence speaks for itself.1-4
Hulio meets the rigorous biosimilar approval standards of the FDA
COMPARATIVE CLINICAL STUDIES
to help ensure no clinically
meaningful differences4
Clinical Pharmacology STUDIES
to show similarity in human
PK/PD/immunogenicity profiles4
Nonclinical Studies
to evaluate biosimilar toxicity
and safety profiles4
Analytical Studies
to support structural and functional
similarity to reference product4
PD=pharmacodynamic; PK=pharmacokinetic.
- An application for a proposed biosimilar generally must include information showing that the proposed product is biosimilar to a reference product4
- The process typically requires analytical studies, nonclinical (animal) studies, clinical pharmacology (pharmacokinetics), and one or more clinical studies4
- For more information about the FDA approval process, please visit the FDA biosimilars review and approval page
Extrapolation
After biosimilarity is confirmed by the totality of evidence, scientific justification may be used to support extrapolation to certain other approved indication(s) of a reference biologic.5
Totality of Evidence
+
Scientific Justification
=
Extrapolation to Additional Indications
Hulio is the only adalimumab biosimilar with 2-year study data
The comparative clinical data required for FDA biosimilar approval were evaluated for an extended period—including the effects of single- and double-switching treatment in a defined population.3
- There was no long-term clinically meaningful difference between HULIO and Humira with respect to safety, efficacy, and immunogenicity3
- There was no impact of switching and double switching between the 2 drugs3
Click below to expand and view the evidence.
Pharmacokinetics (PK) highly similar1
-
Study Design
Results from a Phase I, randomized, double-blind, parallel-group study compared the pharmacokinetic profile of the Viatris biosimilar adalimumab, HULIO, with reference adalimumab sourced from the European Union and the US. A total of 180 healthy subjects (170 men and 10 women of non-childbearing potential) were enrolled.1
-
Concentration vs Time
- HULIO has a PK profile similar to EU-approved and US-licensed adalimumab reference products1
- HULIO was well tolerated by healthy volunteers in this Phase I PK study, with a safety profile similar to that of its reference product1
EU=European Union.
HULIO pharmacokinetics compared to Humira
Efficacy highly similar during double-blind phase2,3
-
Study Design
A randomized, double-blind (DB), phase 3, 24-week study compared the efficacy, safety, and immunogenicity of HULIO with Humira in patients with moderate-to-severe rheumatoid arthritis (RA) inadequately controlled with methotrexate. Patients who completed the DB study were enrolled in the open-label extension (OLE) study and re-randomized 2:1 to receive HULIO or Humira; two-thirds continued on the same treatment and one-third switched for 30 weeks. Then all patients received HULIO for a total duration of 2 years.2,3
-
Mean DAS28-CRP and ACR20 Response Rates Across All Treatment Sequences
Safety profile highly similar during double-blind phase2,3
-
Adverse Reactions at Week 24
- Data shown refer to the same 24-week, double-blind trial as the efficacy data; please see the study design under the efficacy section
- HULIO and the adalimumab reference product have similar clinical safety profiles2
AEs=adverse events; TB=tuberculosis;
TEAE=treatment-emergent adverse event;
TESAE=treatment-emergent serious adverse event.HULIO safety profile compared to Humira
*One patient from Romania died due to treatment-related disseminated TB.
-
Summary of Treatment-emergent Adverse Events of Interest During 2-year Study
- The HULIO and Humira analysis included and 175.4 patient-years, respectively3
- Safety of HULIO was comparable to Humira and maintained over long-term treatment during the open-label extension study, even when patients were switched between HULIO and Humira3
- Please see the study design under the efficacy section
HULIO safety profile compared to Humira
*Related or possibly related to study drug.
Immunogenicity highly similar during double-blind phase2
-
Anti-Drug Antibodies at Week 24
- Data shown refer to the same , double-blind trial as the efficacy data; please see the study design under the efficacy section
- Proportion of patients with anti-drug antibodies (ADA+) was similar between HULIO and Humira groups at
HULIO immunogenicity (ADA+) compared to Humira
-
Anti-Drug Antibodies During 2-year Study
- Neutralizing anti-drug antibodies (ADAs) did not increase in any sequence during the study3
- Switching treatment between Humira and HULIO did not impact ADA response3
- Please see the study design under the efficacy section
HULIO immunogenicity (ADA+) compared to Humira during 2-year study
References: 1. Puri A, Niewiarowski A, Arai Y, et al. Pharmacokinetics, safety, tolerability and immunogenicity of FKB327, a new biosimilar medicine of adalimumab/Humira, in healthy subjects. Br J Clin Pharmacol. 2017;83(7):1405-1415. 2. Alten R, Glover J, Matsunaga N, Chisholm D, Genovese M. Efficacy and safety results of a Phase III study comparing FKB327, an adalimumab biosimilar, with the adalimumab reference product in patients with active rheumatoid arthritis. Presented at: EULAR Annual European Congress of Rheumatology; June 14, 2017; Madrid, Spain. 3. Genovese MC, Kellner H, Arai Y, Muniz R, Alten R. Long-term safety, immunogenicity and efficacy comparing FKB327 with the adalimumab reference product in patients with active rheumatoid arthritis: data from randomised double-blind and open-label extension studies. RMD Open. 2020;6:e000987. 4. US Food and Drug Administration. Biosimilars: review and approval. 2022. Accessed April 24, 2023. https://www.fda.gov/drugs/biosimilars/review-and-approval 5. US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. April 2015. Accessed April 24, 2023. https://www.fda.gov/media/82647/download
Important Safety Information and Indications
SERIOUS INFECTIONS
Patients treated with adalimumab products including HULIO® (adalimumab-fkjp) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Discontinue HULIO if a patient develops a serious infection or sepsis.
Discontinue HULIO if a patient develops a serious infection or sepsis.
Reported infections include:
- Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HULIO use and during therapy. Initiate treatment for latent TB prior to HULIO use.
- Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
- Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.
Carefully consider the risks and benefits of treatment with HULIO prior to initiating therapy in patients:
1) with chronic or recurrent infection, 2) who have been exposed to TB, 3) with a history of opportunistic infection, 4) who resided in or traveled in regions where mycoses are endemic, 5) with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HULIO, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
- Do not start HULIO during an active infection, including localized infections.
- Patients older than 65 years, patients with comorbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
- If an infection develops, monitor carefully and initiate appropriate therapy.
- Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HULIO with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6-MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.
- Consider the risks and benefits of HULIO treatment prior to initiating or continuing therapy in a patient with known malignancy.
- In clinical trials of some TNF blockers, including adalimumab products, more cases of malignancies were observed among TNF-blocker-treated patients compared to control patients.
- Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with HULIO.
- In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general US population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.
- Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.
HYPERSENSITIVITY
- Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If a serious allergic reaction occurs, stop HULIO and institute appropriate therapy.
HEPATITIS B VIRUS REACTIVATION
- Use of TNF blockers, including HULIO, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
- Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.
- Exercise caution in patients who are carriers of HBV and monitor them during and after HULIO treatment.
- Discontinue HULIO and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HULIO after HBV treatment.
NEUROLOGIC REACTIONS
- TNF blockers, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.
- Exercise caution when considering HULIO for patients with these disorders; discontinuation of HULIO should be considered if any of these disorders develop.
- There is a known association between intermediate uveitis and central demyelinating disorders.
HEMATOLOGIC REACTIONS
- Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products.
- Consider stopping HULIO if significant hematologic abnormalities occur.
CONGESTIVE HEART FAILURE
- Worsening and new-onset congestive heart failure (CHF) have been reported with TNF blockers. Cases of worsening CHF have been observed with adalimumab products; exercise caution and monitor carefully.
AUTOIMMUNITY
- Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.
IMMUNIZATIONS
- Patients on HULIO should not receive live vaccines.
- Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HULIO therapy.
- Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live- attenuated vaccines in infants exposed to HULIO in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.
ADVERSE REACTIONS
- The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.
INDICATIONS
Please see accompanying Full Prescribing Information including BOXED WARNING.