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Prescribing information
Medication guide

STARJEMZA™ is a biosimilar to Stelara®

Stelara® is a registered trademark of Johnson & Johnson.

It can be used for the same approved uses as Stelara® with comparable safety and efficacy, including treatment of plaque psoriasis, psoriatic arthritis, Crohn’s Disease and ulcerative colitis. Similar to Stelara®, STARJEMZA™ works by blocking signals from inflammatory immune cells that cause symptoms related to disease. 1,3,4

This site is intended for US residents only.

No clinical meaningful difference

Same effectiveness, same safety – new option1,3,5

  • Works the same way as Stelara® and is FDA-approved for all the same uses. You can expect the same safety and effectiveness with STARJEMZA™ over the course of treatment as you would from Stelara®.
  • It is dosed and administered the exact same way as Stelara® for all uses, including prefilled syringes to be given as a shot under the skin for self administration at home or at doctors office by caregiver.
  • Patients currently taking Stelara® can be readily switched to STARJEMZA™ or it can be used for first-time patients, in place of Stelara®.
Read medical studies

STARJEMZA™ works the same way inside your body as Stelara®

That means it stays in your system just as long, and works just as effectively. 5,7

Read medical studies

What is a biosimilar?

A biosimilar is a medicinal product that has gone through extensive analysis and thorough testing to show that there are no clinically meaningful differences in terms of safety, purity, and potency compared to the originator product (in this case Stelara®). Because of the extensive testing and analysis performed, a biosimilar product can be readily used in place of the originator product.5,6

STARJEMZA™ was studied in clinical trials in patients with plaque psoriasis, and is FDA-approved for the same conditions as Stelara®1,2,8

What is plaque psoriasis?

Plaque psoriasis is a chronic auto-immune skin condition that can occur in adults and children. Patients with plaque psoriasis develop scaly patches on their skin that are often raised and red, which can be very itchy and painful and  can sometimes lead to bleeding. 

In a clinical trial of 556 patients with moderate to severe plaque psoriasis, STARJEMZA™ was shown to be as safe and as effective as Stelara®. 

  • STARJEMZA™
  • Stelara®

Reported adverse events occurred at similar rates

0%
0%
0%
0%

Reported adverse events

Treatment
related

Symptom improvement over time

0%
0%
0%
0%

Week 8

Week 12

75%

saw clearer skin within 12 weeks, in the original clinical trials with Stelara®

What is plaque psoriasis?

Plaque psoriasis is a chronic auto-immune skin condition that can occur in adults and children. Patients with plaque psoriasis develop scaly patches on their skin that are often raised and red, which can be very itchy and painful and  can sometimes lead to bleeding. 

STARJEMZA™ is also FDA approved for children between the ages of 6 and 17 with plaque psoriasis. It is unknown whether STARJEMZA™ can be used in children under the age of 6 years old as it has not been tested in this group of patients.

What is psoriatric arthritis?

Some people with plaque psoriasis can also develop psoriatic arthritis, an inflammatory condition that results in swelling of one or more joints, causing pain, stiffness, and reduced range of motion. In patients with psoriatic arthritis, fingers and toes are the most common joints affected, but knee, hips and the spine can also be affected.

In clinical trials with Stelara®, nearly half of patients (46%) showed at least a 20% improvement in their joint symptoms.

What is psoriatric arthritis?

Some people with plaque psoriasis can also develop psoriatic arthritis, an inflammatory condition that results in swelling of one or more joints, causing pain, stiffness, and reduced range of motion. In patients with psoriatic arthritis, fingers and toes are the most common joints affected, but knee, hips, and the spine can also be affected.

STARJEMZA™ is also FDA approved for children between the ages of 6 and 17 with psoriatic arthritis. It is unknown whether STARJEMZA™ can be used in children under the age of 6 years old as it has not been tested in this group of patients.

What is crohn’s disease?

Crohn’s disease is a type of inflammatory bowel disease (IBD) that causes chronic swelling and irritation in the digestive tract. Patients with Crohn’s Disease often suffer from stomach pain, severe diarrhea, fatigue, and weight loss, which can be debilitating and can lead to serious or life-threatening complications.

In clinical trials with Stelara®, 56% of patients experienced relief from their symptoms within 6 weeks, while greater than half (53%) of patients went into remission after 1 year of treatment.

0%

experienced symptom relief within 6 weeks

0%

were in remission after 1 year

What is crohn’s disease?

Crohn’s disease is a type of inflammatory bowel disease (IBD) that causes chronic swelling and irritation in the digestive tract. Patients with Crohn’s Disease often suffer from stomach pain, severe diarrhea, fatigue, and weight loss, which can be debilitating and can lead to serious or life-threatening complications.

What is ulcerative colitis?

Ulcerative colitis is an inflammatory condition that causes sores (ulcers) in parts of the digestive tract, especially  the colon and the rectum, which can lead to stomach pain, diarrhea, and bleeding.

In clinical trials with Stelara®, 58% of patients experienced relief from their symptoms while 20% of patients were in remission within 8 weeks. Within 1 year, 45% of patients were in remission from their disease.

After 8 weeks

58%

experienced symptom relief

20%

were in remission

After 1 year

45%

were in remission

What is ulcerative colitis?

Ulcerative colitis is an inflammatory condition that causes sores (ulcers) in parts of the digestive tract, especially  the colon and the rectum, which can lead to stomach pain, diarrhea, and bleeding.

STARJEMZA™ was studied in clinical trials in patients with plaque psoriasis, and is FDA-approved for the same conditions as Stelara®1,2,8

In a clinical trial of 556 patients with moderate to severe plaque psoriasis, STARJEMZA™ was shown to be as safe and as effective as Stelara®. 

  • STARJEMZA™
  • Stelara®

Reported adverse events occurred at similar rates

0%
0%
0%
0%

Reported adverse events

Treatment
related

Symptom improvement over time

0%
0%
0%
0%

Week 8

Week 12

75%

saw clearer skin within 12 weeks, in the original clinical trials with Stelara®

What is plaque psoriasis?

Plaque psoriasis is a chronic auto-immune skin condition that can occur in adults and children. Patients with plaque psoriasis develop scaly patches on their skin that are often raised and red, which can be very itchy and painful and  can sometimes lead to bleeding. 

In clinical trials with Stelara®, nearly half of patients (46%) showed at least a 20% improvement in their joint symptoms.

What is psoriatric arthritis?

Some people with plaque psoriasis can also develop psoriatic arthritis, an inflammatory condition that results in swelling of one or more joints, causing pain, stiffness, and reduced range of motion. In patients with psoriatic arthritis, fingers and toes are the most common joints affected, but knee, hips, and the spine can also be affected.

In clinical trials with Stelara®, 56% of patients experienced relief from their symptoms within 6 weeks, while greater than half (53%) of patients went into remission after 1 year of treatment

0%

went into remission after 1 year

0%

experienced symptom relief within 6 weeks

What is crohn’s disease?

Crohn’s disease is a type of inflammatory bowel disease (IBD) that causes chronic swelling and irritation in the digestive tract. Patients with Crohn’s Disease often suffer from stomach pain, severe diarrhea, fatigue, and weight loss, which can be debilitating and can lead to serious or life-threatening complications.

In clinical trials with Stelara®, 58% of patients experienced relief from their symptoms while 20% of patients were in remission within 8 weeks. Within 1 year, 45% of patients were in remission from their disease.

After 8 weeks

58%

experienced symptom relief

20%

were in remission

After 1 year

45%

were in remission

What is ulcerative colitis?

Ulcerative colitis is an inflammatory condition that causes sores (ulcers) in parts of the digestive tract, especially  the colon and the rectum, which can lead to stomach pain, diarrhea, and bleeding.

Starting or switching to STARJEMZA™ ?

Read more about how you can get started with STARJEMZA™

Taking STARJEMZA™
Important Safety Information for STARJEMZA™ (ustekinumab-hmny) Injection

Contraindications

STARJEMZA™ is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in STARJEMZA™.

Warnings & precautions

  • Infections – Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab products.  Avoid initiating treatment with STARJEMZA™ in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of STARJEMZA™ in patients with a chronic infection or a history of recurrent infection. Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following:
    • Plaque Psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, and urinary tract infections.
    • Psoriatic arthritis: cholecystitis.
    • Crohn’s disease: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeria meningitis.
    • Ulcerative colitis: gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis.
  • Theoretical Risk for Vulnerability to Particular Infections –  Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations.  Serious infections and fatal outcomes have been reported in such patients.
  • Pre-treatment Evaluation for Tuberculosis – Evaluate patients for tuberculosis infection prior to initiating treatment with STARJEMZA™.  Avoid administering STARJEMZA™ to patients with active tuberculosis infection.
  • Malignancies – Ustekinumab products are immunosuppressants and may increase the risk of malignancy.  The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy.  There have been post-marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had pre-existing risk factors for developing non-melanoma skin cancer.
  • Hypersensitivity Reactions – Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STARJEMZA™.
  • Posterior Reversible Encephalopathy Syndrome (PRES) – Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis, and Crohn’s disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab product initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab products. Monitor all patients treated with STARJEMZA™ for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue STARJEMZA™.
  • Immunizations – Prior to initiating therapy with STARJEMZA™, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with STARJEMZA™ should avoid receiving live vaccines. Avoid administering BCG vaccines during treatment with STARJEMZA™ or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving STARJEMZA™ because of the potential risk for shedding from the household contact and transmission to patient. Non-live vaccinations received during a course of STARJEMZA™ may not elicit an immune response sufficient to prevent disease.
  • Noninfectious Pneumonia – Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. If diagnosis is confirmed, discontinue STARJEMZA™ and institute appropriate treatment.

Adverse reactions

Serious adverse reactions associated with STARJEMZA™ include Infections, Malignancies, Hypersensitivity Reactions, Posterior Reversible Encephalopathy Syndrome (PRES), and Noninfectious Pneumonia.

  • Immunogenicity – Approximately 6 to 12.4% of subjects treated with ustekinumab in plaque psoriasis and psoriatic arthritis clinical trials developed antibodies to ustekinumab, which were generally low-titer. In plaque psoriasis clinical trials, antibodies to ustekinumab were associated with reduced or undetectable serum ustekinumab concentrations and reduced efficacy. In plaque psoriasis trials, the majority of subjects who were positive for antibodies to ustekinumab had neutralizing antibodies. In Crohn’s disease and ulcerative colitis clinical trials, 2.9% and 4.6% of subjects, respectively, developed antibodies to ustekinumab when treated with ustekinumab for approximately one year. No apparent association between the development of antibodies to ustekinumab and the development of injection site reactions was seen.
  • Postmarketing Experience – The following adverse reactions have been reported during post-approval use of ustekinumab products:
      • Immune system disorders: Serious hypersensitivity reactions (including anaphylaxis and angioedema), other hypersensitivity reactions (including rash and urticaria).
      • Infections and infestations: Lower respiratory tract infection (including opportunistic fungal infections and tuberculosis).
      • Neurological disorders: Posterior Reversible Encephalopathy Syndrome (PRES).
      • Respiratory, thoracic, and mediastinal disorders: Interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia.
      • Skin reactions: Pustular psoriasis, erythrodermic psoriasis, hypersensitivity vasculitis.

Drug interactions

  • Concomitant Therapies –  In plaque psoriasis trials the safety of ustekinumab products in combination with immunosuppressive agents or phototherapy has not been evaluated. In psoriatic arthritis trials, concomitant MTX use did not appear to influence the safety or efficacy of ustekinumab. In Crohn’s disease and ulcerative colitis induction trials, immunomodulators (6-MP, AZA, MTX) were used concomitantly in approximately 30% of subjects and corticosteroids were used concomitantly in approximately 40% and 50% of Crohn’s disease and ulcerative colitis subjects, respectively. Use of these concomitant therapies did not appear to influence the overall safety or efficacy of ustekinumab.
  • CYP450 Substrates – The formation of CYP450 enzymes can be suppressed by increased levels of certain cytokines (e.g., IL-1, IL-6, TNFα, IFN) during chronic inflammation. Thus, use of ustekinumab products, antagonists of IL-12 and IL-23, could normalize the formation of CYP450 enzymes. A CYP-mediated drug interaction effect was not observed in subjects with Crohn’s disease.
  • Allergen Immunotherapy – Ustekinumab products have not been evaluated in patients who have undergone allergy immunotherapy. Ustekinumab products may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.

Indications and usage

STARJEMZA™ is indicated for the treatment of:

    • adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
    • adults and pediatric patients 6 years of age and older with active psoriatic arthritis.
    • adult patients with moderately to severely active Crohn’s disease.
    • adult patients with moderately to severely active ulcerative colitis.

For additional Important Safety Information, please refer to the Package Insert for full prescribing information, available on www.hikma.com.

To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800 FDA-1088 or www.fda.gov/medwatch.

For Product Inquiry call 1-877-845-0689.

Manufactured by:
Bio-Thera Solutions, Ltd.
155 Yaotianhe Street, Huangpu District,
Guangzhou, Guangdong, China 511356

Distributed By:
Hikma Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922 USA

Important Safety Information for STARJEMZA™ (ustekinumab-hmny) Injection

Contraindications

STARJEMZA™ is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in STARJEMZA™.

References: 1. Starjemza™ Prescribing information. Hikma ; October 2024. 2. Jeremias S. FDA approves Starjemza™ as new Stelara® biosimilar. The Center for Biosimilars. May 27, 2025. Accessed July 28, 2025. https://www.centerforbiosimilars.com/view/fda-approves-starjemza-as-new-stelara-biosimilar 3. STELARA®. Prescribing information. Janssen Biotech, Inc.; November 2024. 4. Amaral C, Rodrigues AR, Veiga F, Bell V. Biosimilar medicines; from development process to marketing authorization by the EMA and FDA. Appl Sci. 2024;14(17):7529. 5. US Food and Drug Administration. Biosimilar regulatory review and approval. Accessed July 28, 2025. https://www.fda.gov/media/151061/download. 6. Wu M, Li X, Yang D, et al. Comparison of pharmacokinetic similarity, immunogenicity, and safety of ustekinumab and BAT2206 in healthy Chinese male subjects in a double-blind, randomized, single-dose, parallel-group phase I trial. BioDrugs. 2022;37(1):89-98. doi:10.1007/s40259-022-00563-5. 7. Wu M, Li X, Yang D, et al. Comparison of pharmacokinetic similarity, immunogenicity, and safety of ustekinumab and BAT2206 in healthy Chinese male subjects in a double-blind, randomized, single-dose, parallel-group phase I trial. BioDrugs. 2022;37(1):89-98. doi:10.1007/s40259-022-00563-5. 8. Man X, Zaharieva K, Pulka G, et al. A randomized phase III study to compare efficacy and safety of BAT2206 (proposed ustekinumab biosimilar) with reference ustekinumab in patients with moderate to severe plaque psoriasis. J Am Acad Dermatol. 2025;92(4):724-731. doi:10.1016/j.jaad.2024.10.10