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A changing series of people smiling
A changing series of people smiling
A changing series of people smiling
A changing series of people smiling
A changing series of people smiling
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Click, Click,

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Don’t miss a beat with the Humira® (adalimumab) biosimilar designed to make the treatment experience as simple as possible for you and your patients.

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Prescribe with ease

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Treat with confidence

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Hello Hulio

Hulio prefilled penHulio prefilled pen

HULIO is a biosimilar from Biocon Biologics, a global expert in biosimilars. HULIO is hitting the States after 5 years of experience outside of the US.1,2 It is a proven biosimilar that's ready to work for patients in the real world—starting with an easy-to-use 2-click prefilled pen.3

Meet HULIO

If you know Humira, you know Hulio

HULIO doesn't just sound similar to Humira. The totality of evidence has shown HULIO to be highly similar to and have no clinically meaningful differences from Humira in terms of safety and effectiveness.4,5 All boxes checked.

See the Clinical Data
 
HUMIRA
HULIO
Molecular structure
Yes
Yes
Biological function
yes
yes
Safety profile
yes
yes
Demonstrated efficacy
yes
yes
Immunogenicity profile
yes
yes
Drug stability
yes
yes
Drug purity
yes
yes

Pharmacokinetic profile

yes
yes

Dosing with no surprises

Whether starting your patients on HULIO or transitioning them from Humira, HULIO offers you the same familiar dosing you've come to expect from Humira.5,6 See how similar HULIO is within your specialty.

Onboarding made simple

  • HULIO360 Patient Onboarding Specialists help patients with the initial onboarding details—from benefits verification and prior authorization support to copay assistance and prescription triage

  • Patients can be enrolled automatically when you prescribe HULIO

Learn How

You initiate a HULIO
prescription

Enrolling your patients
in all-around support

Designed to provide a
positive experience

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Hulio 360
has your patient’s back

When you prescribe HULIO, your patients have a friend in HULIO360. Services and support surround them before, during, and after their first dose, helping them get going and keep going toward their treatment goals. Should you or your patients need assistance, HULIO360 Patient Support Services is available Monday-Friday 8 AM-8 PM ET by calling 1-833-44-HULIO (1-833-444-8546).

More About HULIO360

References:

1Hulio. Product information. European Medicines Agency; 2022. Accessed March 20, 2023. https://www.ema.europa.eu/en/medicines/human/EPAR/hulio 2Hulio. Product information. Health Canada; 2022. Accessed March 20, 2023. https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99197 3Serrecchia T, Waller KA, Ishikawa T, Muniz R, Varricchione TR. Human factors validation for a rheumatoid arthritis auto-injector for the adalimumab biosimilar FKB327. Int J Hum Factors Ergon. 2020;7(2):144-160. 4US Food and Drug Administration. Biosimilars: review and approval. 2022. Accessed April 24, 2023. https://www.fda.gov/drugs/biosimilars/review-and-approval 5HULIO. Prescribing information. Biocon Biologics Inc; 2023. 6HUMIRA. Prescribing information. AbbVie Inc; 2021. 

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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.

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

  • 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.

Please see accompanying Full Prescribing Information including BOXED WARNING.

Contact Us

contact.us@bioconbiologics.com
1-844-348-3404

HUMIRA® is a registered trademark of AbbVie Inc.

HULIO® is a registered trademark of Fujifilm Kyowa Kirin Biologics Co., Ltd., licensed use by Biosimilar Collaborations Ireland Limited, a Biocon Biologics Company.

Hulio360 is a trademark of Fujifilm Kyowa Kirin Biologics Co., Ltd., licensed to Biosimilar Collaborations Ireland Ltd., a Biocon Biologics company.

© 2023 Biocon Biologics Inc. All Rights Reserved. HUL-2023-0119 V2