Pyzchiva (Ustekinumab Biosimilar)

What Is Pyzchiva and What Is It Used For?

Quick Answer: Pyzchiva is a biosimilar of ustekinumab — a biologic medicine that blocks interleukin-12 (IL-12) and interleukin-23 (IL-23), two proteins central to inflammatory immune responses. It is approved to treat moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe Crohn's disease, and moderate to severe ulcerative colitis. It has the same active substance and indications as the reference medicine STELARA.

Pyzchiva contains the active substance ustekinumab, a fully human IgG1 kappa monoclonal antibody produced by recombinant DNA technology in a well-characterised mammalian cell line. Monoclonal antibodies are laboratory-engineered proteins designed to recognise and bind a specific target molecule in the body with high precision. In the case of ustekinumab, the target is the p40 protein subunit shared by both IL-12 and IL-23. By binding to this shared subunit, ustekinumab prevents these cytokines from interacting with their IL-12Rβ1 receptor on immune cells, thereby dampening the overactive Th1 and Th17 immune pathways that drive chronic inflammation.

Pyzchiva belongs to the pharmacological class of immunosuppressants and, more specifically, to the group of interleukin inhibitors. Unlike broad-spectrum immunosuppressants such as corticosteroids or ciclosporin, its mechanism of action is highly selective. This targeted approach has contributed to a favourable long-term safety profile observed with ustekinumab-based medicines since their original approval in 2009, a profile that has been confirmed across multiple real-world registries and long-term extension studies.

What Is a Biosimilar?

A biosimilar is a biologic medicine that is highly similar to an already authorised biologic (the "reference medicine"), with no clinically meaningful differences in terms of safety, purity, or efficacy. Biosimilars are not generic medicines; because biologics are produced in living cells, small differences are inherent even between batches of the reference product. Regulatory agencies such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) require biosimilar developers to demonstrate this high similarity through a comprehensive comparability exercise that includes analytical (physicochemical and biological) characterisation, non-clinical studies, and clinical studies in relevant patient populations.

Pyzchiva (development code SB17) was developed by Samsung Bioepis and has undergone this rigorous comparability programme against reference ustekinumab. Pivotal clinical evidence includes a Phase 3 randomised, double-blind, comparative trial in adults with moderate to severe plaque psoriasis, which confirmed equivalent efficacy (measured by PASI 75 response at week 12) and comparable safety, pharmacokinetics, and immunogenicity versus the reference product. On this basis, Pyzchiva received EMA marketing authorisation in 2024 for all indications of the reference ustekinumab, through the principle of extrapolation supported by a shared mechanism of action.

Plaque Psoriasis

Plaque psoriasis is a chronic, immune-mediated skin disease characterised by raised, red, scaly plaques, most commonly on the scalp, elbows, knees, and lower back. It affects approximately 2–3% of the global population and is associated with significant impact on quality of life, mental health, and cardiovascular risk. Pyzchiva is approved for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and for children and adolescents aged 6 years and older with moderate to severe disease who have not responded adequately to, or cannot tolerate, other systemic treatments or phototherapy.

Reference ustekinumab demonstrated strong efficacy in the pivotal PHOENIX 1 and PHOENIX 2 clinical trials, where approximately 67–76% of patients achieved at least a 75% improvement in their Psoriasis Area and Severity Index (PASI 75) score by week 12, compared with 3–4% on placebo. Responses were sustained over five years of continuous therapy. Because Pyzchiva is highly similar to reference ustekinumab, these efficacy expectations apply to Pyzchiva as well, supported by the comparative Phase 3 trial in psoriasis.

Psoriatic Arthritis

Psoriatic arthritis (PsA) is a chronic inflammatory arthritis that affects up to 30% of people with psoriasis. It can cause joint pain, swelling, morning stiffness, enthesitis (inflammation where tendons attach to bone), dactylitis ("sausage digits"), and, if untreated, progressive joint damage. Pyzchiva is indicated for adults with active psoriatic arthritis who have had an inadequate response to prior disease-modifying anti-rheumatic drug (DMARD) therapy such as methotrexate. It can be used as monotherapy or in combination with methotrexate.

In the PSUMMIT 1 and PSUMMIT 2 programmes conducted with reference ustekinumab, treatment improved peripheral arthritis, enthesitis, dactylitis, skin symptoms, and physical function compared with placebo, and slowed radiographic progression of joint damage. The biosimilar pathway and extrapolation principles allow these benefits to be expected with Pyzchiva under the same dosing regimen.

Crohn's Disease

Crohn's disease is a chronic inflammatory bowel disease (IBD) that can affect any part of the gastrointestinal tract from the mouth to the anus, most commonly the terminal ileum and colon. Symptoms include persistent abdominal pain, diarrhoea, weight loss, fatigue, and perianal complications. Pyzchiva is approved for adults and for children aged 6 years and older weighing at least 40 kg with moderate to severe Crohn's disease who have had an inadequate response to, lost response to, or were intolerant of conventional therapy (such as corticosteroids and immunomodulators) or a tumour necrosis factor (TNF) alpha inhibitor.

The UNITI-1, UNITI-2, and IM-UNITI trials of reference ustekinumab demonstrated that a single weight-based intravenous induction dose, followed by subcutaneous maintenance every 8 or 12 weeks, induced and maintained clinical remission in a significant proportion of patients, including those who had previously failed anti-TNF therapy. This same regimen is used with Pyzchiva.

Ulcerative Colitis

Ulcerative colitis (UC) is a chronic inflammatory bowel disease that causes continuous inflammation and ulceration of the inner lining of the colon and rectum, leading to bloody diarrhoea, urgency, and abdominal discomfort. Pyzchiva is indicated for adults with moderate to severe ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant of conventional therapy or a biologic agent (TNF inhibitor or vedolizumab).

In the UNIFI programme of reference ustekinumab, intravenous induction followed by subcutaneous maintenance significantly improved clinical response, clinical remission, and endoscopic improvement versus placebo, including in bio-naïve and bio-experienced populations. These benefits are expected with Pyzchiva under the same treatment schedule.

What Should You Know Before Taking Pyzchiva?

Quick Answer: Before starting Pyzchiva, your doctor will evaluate you for active infections (especially tuberculosis), review your vaccination history, and assess your risk for cancer and other relevant conditions. Do not take Pyzchiva if you are allergic to ustekinumab or any excipient, or if you have a clinically significant active infection.

Contraindications

Do not use Pyzchiva if you have a known hypersensitivity (allergy) to ustekinumab or to any of the excipients in the product. Serious allergic reactions, including anaphylaxis, have been reported rarely with ustekinumab-based medicines. Symptoms of a severe allergic reaction include difficulty breathing or swallowing, swelling of the face, lips, tongue, or throat, severe itching or hives, dizziness, or low blood pressure.

Pyzchiva should also not be started in patients with an active, clinically significant infection such as active tuberculosis (TB), severe sepsis, or a significant opportunistic infection. Before starting therapy, your doctor will take a thorough medical history, perform a clinical examination, and arrange testing for TB (usually a tuberculin skin test or an interferon-gamma release assay, such as QuantiFERON-TB Gold or T-SPOT.TB). If latent TB is identified, appropriate anti-TB treatment must be initiated before Pyzchiva is started.

Warnings and Precautions

Because Pyzchiva selectively modulates the immune system, several precautions apply. Inform your doctor before starting treatment about all of your medical history, current conditions, and medicines (including over-the-counter products, herbal supplements, and recent vaccinations).

• Serious and opportunistic infections: Pyzchiva may increase the risk of infections, including serious bacterial, mycobacterial (TB), invasive fungal, viral, or parasitic infections. Tell your doctor if you have recurrent infections, chronic infections such as hepatitis B or C, or if you have recently travelled to areas where fungal infections (e.g., histoplasmosis, coccidioidomycosis) are endemic.
• Tuberculosis reactivation: All patients must be screened for latent or active TB before starting treatment. Patients with a history of latent TB should receive appropriate prophylaxis. Monitor for signs of active TB (persistent cough, fever, night sweats, weight loss) during and after therapy, even if initial screening was negative.
• Hypersensitivity reactions: Rare cases of anaphylaxis and other serious hypersensitivity reactions, including angioedema and bronchospasm, have been reported. If a severe reaction occurs, discontinue Pyzchiva immediately and seek emergency care.
• Cancer risk: Immunomodulators may theoretically increase the risk of malignancy. Long-term data with reference ustekinumab have not shown a clear overall increase in cancer risk, but non-melanoma skin cancer has been reported, particularly in patients with extensive prior phototherapy. Patients with a history of cancer should be evaluated individually.
• Skin surveillance: Report any new or changing skin lesions, moles, or non-healing sores to your doctor. Regular dermatological examination is advisable for patients with additional risk factors for skin cancer.
• Reversible posterior leukoencephalopathy syndrome (RPLS): Very rare cases of RPLS have been reported with ustekinumab. Seek urgent medical care if you experience severe headache, altered mental status, vision loss, or seizures.
• Lupus-like reactions: Cutaneous lupus and lupus-like syndrome have been reported rarely. Report any red, raised, scaly rash on sun-exposed skin, especially if combined with joint pain.
• Older adults (≥ 65 years): Efficacy appears similar to younger adults, but older patients may have a higher risk of infections and should be monitored closely.
• Surgery: Inform your surgical and anaesthetic team that you are using Pyzchiva. Treatment may be paused temporarily around major surgery, based on individual risk assessment.

Vaccinations

Live vaccines (including BCG, MMR, varicella, rotavirus, live attenuated influenza, and yellow fever) should not be given during treatment with Pyzchiva because of the theoretical risk of vaccine-related infection. Ideally, bring your vaccination status up to date before starting therapy, with live vaccines completed at least 2 weeks before the first Pyzchiva dose. Inactivated vaccines (such as seasonal inactivated influenza, pneumococcal, and COVID-19 vaccines) can generally be administered during treatment, although antibody responses may be somewhat reduced.

Children and Adolescents

Pyzchiva is approved for children aged 6 years and older with moderate to severe plaque psoriasis, and for children aged 6 years and older weighing at least 40 kg with moderate to severe Crohn's disease. It is not recommended for children under 6 years of age for any indication, for children with psoriatic arthritis, or for children with ulcerative colitis, because clinical experience in these populations is lacking. Paediatric dosing for psoriasis is weight-based, and a paediatric gastroenterologist should supervise Crohn's disease treatment.

Pregnancy and Breastfeeding

There is limited clinical experience with ustekinumab-based medicines during human pregnancy. Animal studies have not shown direct or indirect harmful effects on reproduction or fetal development. As a precaution, Pyzchiva should be avoided during pregnancy unless clearly necessary, after a careful individual benefit–risk assessment.

Women of childbearing potential should use effective contraception during treatment and for at least 15 weeks after the last dose of Pyzchiva. Because ustekinumab is an IgG antibody, it can cross the placenta, particularly in the second and third trimesters, and may be detectable in the infant's serum after birth. If you received Pyzchiva during pregnancy, inform your baby's doctor so that live vaccines (such as BCG, MMR, or rotavirus) can be safely deferred, generally for the first 12 months of life, unless otherwise advised.

Small amounts of ustekinumab may be excreted in breast milk. The clinical impact on the breastfed infant is unclear. You and your doctor should make a shared decision about whether to breastfeed or to continue Pyzchiva, taking into account the benefit of breastfeeding, the mother's need for treatment, and any potential risks.

Driving and Operating Machinery

Pyzchiva has no known or only negligible influence on the ability to drive or operate machinery.

How Does Pyzchiva Interact with Other Drugs?

Quick Answer: Pyzchiva has relatively few drug–drug interactions because ustekinumab is not metabolised by cytochrome P450 enzymes. The most clinically important interactions involve live vaccines (which must be avoided), other immunosuppressive and biologic agents, and a theoretical effect on medicines with a narrow therapeutic index whose clearance may change when chronic inflammation is reduced.

As a monoclonal antibody, ustekinumab is cleared through proteolytic degradation rather than via hepatic CYP450 metabolism. This pharmacokinetic profile means that pharmacokinetic interactions with conventional small-molecule medicines are unlikely. However, several pharmacodynamic and immunological interactions remain clinically important. Always give your doctor and pharmacist an up-to-date list of all prescription medicines, over-the-counter products, vitamins, herbal products, and recent or upcoming vaccinations.

Major Interactions

Other Considerations

Unlike many small-molecule immunosuppressants, ustekinumab does not undergo hepatic metabolism via cytochrome P450 (CYP450) enzymes; it is cleared through normal proteolytic pathways similar to endogenous immunoglobulins. However, chronic systemic inflammation can suppress CYP450 enzyme activity. When Pyzchiva effectively reduces inflammation, CYP450 activity may normalise, which can, in theory, change the plasma levels of concomitant medicines that are CYP450 substrates. This is particularly relevant for narrow-therapeutic-index drugs such as warfarin or ciclosporin, and your doctor may wish to monitor these more closely during the first months of Pyzchiva therapy.

Infant Vaccination After Maternal Pyzchiva Use

If you have received Pyzchiva during pregnancy, it is essential to tell your baby's paediatrician before any vaccinations. Live vaccines such as BCG and rotavirus are generally not recommended during the first 12 months of life for infants exposed in utero, because residual ustekinumab may still be detectable in the infant's bloodstream. Inactivated vaccines can usually be given according to the standard national schedule. The decision should always be individualised in consultation with the baby's paediatrician.

What Is the Correct Dosage of Pyzchiva?

Quick Answer: Pyzchiva dosing depends on the indication and, for some patients, on body weight. For psoriasis and psoriatic arthritis, the standard dose is 45 mg subcutaneously (or 90 mg for patients above 100 kg), given at weeks 0 and 4, then every 12 weeks. For Crohn's disease and ulcerative colitis, treatment starts with a weight-based intravenous infusion (approximately 6 mg/kg), followed by 90 mg subcutaneously every 8 or 12 weeks.

Pyzchiva should be initiated and monitored by a specialist experienced in the diagnosis and treatment of the conditions for which it is used — typically a dermatologist, gastroenterologist, or rheumatologist. Self-injection may be possible after adequate training, but the first injections are usually administered by a healthcare professional to confirm technique and monitor for immediate reactions.

Adults — Plaque Psoriasis and Psoriatic Arthritis

Adults — Crohn's Disease and Ulcerative Colitis

Children and Adolescents (6 years and older) — Plaque Psoriasis

Children (≥ 40 kg) — Crohn's Disease

For children and adolescents weighing at least 40 kg with moderate to severe Crohn's disease, the dosing regimen mirrors adult dosing: a weight-based intravenous induction dose of approximately 6 mg/kg, followed by 90 mg subcutaneously 8 weeks later, then 90 mg every 12 weeks (or every 8 weeks if required based on clinical response). Treatment decisions should be made by a paediatric gastroenterologist experienced in inflammatory bowel disease.

Older Adults

No specific dose adjustment is required for adults aged 65 years and older. The same dosing schedule applies. Because older adults may be more susceptible to infections, closer clinical monitoring is advisable, particularly during the first months of therapy.

Renal and Hepatic Impairment

Pyzchiva has not been specifically studied in patients with renal or hepatic impairment. As a monoclonal antibody, ustekinumab is cleared by proteolytic degradation and is not expected to require dose adjustment based on kidney or liver function, but treatment should be individualised in severe organ impairment.

Missed Dose

If you miss a scheduled dose of Pyzchiva, contact your doctor or specialist nurse as soon as possible. Do not take a double dose to make up for a missed injection. Your team will advise whether to take the missed dose immediately and then continue on the original schedule, or to restart the cycle. Try to store the injection reminder and the name, strength, and batch number of your product so that any missed dose can be recorded accurately.

Overdose

If you have received or been given more Pyzchiva than prescribed, contact your doctor, pharmacist, or local poison information centre immediately, and bring the outer packaging of the medicine, even if empty. Clinical experience with accidental overdose is limited. In studies of reference ustekinumab, single doses up to 6 mg/kg intravenously were administered without dose-limiting toxicity. Management in the event of overdose is supportive: the patient should be monitored for signs of adverse reactions, particularly infections, and appropriate symptomatic treatment should be given.

How Pyzchiva Is Administered

Pyzchiva is administered as a subcutaneous (under-the-skin) injection for psoriasis, psoriatic arthritis, and maintenance treatment of Crohn's disease and ulcerative colitis. For Crohn's disease and ulcerative colitis, the initial induction dose is given as an intravenous (IV) infusion in a healthcare facility, usually over at least 1 hour, with observation during and after the infusion.

After appropriate training by a qualified healthcare professional, patients or their caregivers may be able to self-administer the subcutaneous maintenance doses at home. Suitable injection sites include the upper front of the thigh, the abdomen (at least 5 cm away from the navel), or the upper arm (if someone else is injecting). Avoid injecting into skin that is affected by psoriasis plaques, or into skin that is red, bruised, tender, hard, broken, or scarred. Rotate injection sites at each dose to reduce the risk of local skin reactions.

What Are the Side Effects of Pyzchiva?

Quick Answer: Like all biologic medicines, Pyzchiva can cause side effects, although not everyone experiences them. Most side effects — such as upper respiratory infections, headache, fatigue, and injection site reactions — are mild to moderate. Serious but rare side effects include severe allergic reactions, serious infections (including tuberculosis), and, very rarely, neurological or skin conditions such as RPLS, exfoliative dermatitis, or lupus-like reactions.

The safety profile of Pyzchiva mirrors that of reference ustekinumab, which has been evaluated in extensive clinical trials across psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, involving many thousands of patients. Long-term safety data spanning more than a decade of continuous treatment in psoriasis and several years in IBD indicate a consistent profile, without unexpected late-emerging safety signals. The comparative Phase 3 study of Pyzchiva versus reference ustekinumab in psoriasis showed a similar frequency and pattern of adverse events.

Infections During Treatment

Because Pyzchiva modulates parts of the immune system, it may increase susceptibility to infections. These can range from common upper respiratory infections to more serious bacterial, viral, fungal, or parasitic infections. Opportunistic infections — infections that usually occur in people with weakened immune systems — have been reported, including pulmonary tuberculosis, invasive fungal infections, and severe viral infections.

Contact your doctor promptly if you develop any of the following during Pyzchiva treatment:

• Persistent fever, night sweats, or unexplained weight loss
• New or worsening cough, shortness of breath, or chest pain
• Warm, red, painful skin, or a painful blistering rash
• Burning sensation when urinating, or pelvic pain
• Persistent diarrhoea, especially with blood or fever
• Severe headache, stiff neck, sensitivity to light, nausea, or confusion
• Visual disturbances or vision loss

Your doctor may decide to pause Pyzchiva temporarily until an infection is controlled. Do not stop or restart Pyzchiva without medical advice, as abrupt discontinuation may lead to return of the underlying inflammatory disease.

Injection Site Reactions

Injection site reactions are among the most common adverse events with subcutaneous biologics, including Pyzchiva. They typically present as mild redness, pain, itching, bruising, hardness, or swelling at the site of injection, often resolving within days. Applying a cool compress, rotating injection sites, and ensuring the medicine reaches room temperature before injection can reduce discomfort. Contact your doctor if injection site reactions are severe, persistent, or accompanied by systemic symptoms.

Reporting Side Effects

For biologic medicines, including biosimilars, traceability is especially important. If you experience any side effect while on Pyzchiva, report the specific brand name ("Pyzchiva") and, where possible, the batch number to your doctor or national medicines authority (such as the MHRA Yellow Card scheme, the FDA MedWatch programme, or the EMA EudraVigilance system). This helps regulators monitor the long-term safety of individual biologic products.

How Should You Store Pyzchiva?

Quick Answer: Store Pyzchiva in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze and do not shake. Keep the vial or prefilled syringe in its original carton to protect from light. Use the product within the approved expiry date and do not use if the solution is discoloured, cloudy, or contains foreign particles.

Pyzchiva is a biologic medicine, so its active ingredient is a large, folded protein that can be damaged by temperature extremes, light, agitation, and mechanical stress. Correct storage is therefore essential to maintain both safety and efficacy.

• Temperature: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not place near the freezer compartment or on the back wall of the refrigerator where accidental freezing can occur. If Pyzchiva has been frozen, do not use it.
• Protection from light: Keep the vial or prefilled syringe in its original carton until use to protect it from light.
• Do not shake: Vigorous shaking can denature the antibody and reduce efficacy.
• Room-temperature window: Before injection, Pyzchiva may be left at room temperature (up to 30°C / 86°F) for a limited period, as described in the product leaflet. Do not refrigerate it again after it has been left at room temperature if the leaflet advises against this.
• Keep out of sight and reach of children.
• Expiry date: Do not use Pyzchiva after the expiry date printed on the label and carton. The expiry refers to the last day of the stated month.
• Visual inspection: Always inspect the solution before injection. It should be clear to slightly opalescent and colourless to light yellow. Do not use if it is discoloured, cloudy, or contains visible particles (other than a few small translucent protein flecks, which are normal).
• Single use only: Pyzchiva vials and prefilled syringes are for single use. Any residual solution must be discarded.

Dispose of unused Pyzchiva and used needles in accordance with local regulations — typically via a sharps container and through a pharmacy or medical waste programme. Do not discard medicines in household waste or wastewater. These precautions help protect both public health and the environment.

What Does Pyzchiva Contain?

Quick Answer: The active substance in Pyzchiva is ustekinumab. Each vial contains 45 mg of ustekinumab in 0.5 mL of solution. Inactive ingredients include L-histidine and L-histidine monohydrochloride monohydrate (buffers), polysorbate 80 (stabiliser), sucrose (stabiliser), and water for injections.

The active substance in Pyzchiva is ustekinumab, a fully human IgG1 kappa monoclonal antibody produced by recombinant DNA technology in a well-characterised mammalian cell line. As a biosimilar to reference ustekinumab, Pyzchiva has been shown to be highly similar in amino acid sequence, higher-order structure, post-translational modifications, biological activity, and pharmacokinetic behaviour.

Inactive Ingredients (Excipients)

• L-histidine — acts as a buffer to maintain the correct pH of the solution and protect the antibody's three-dimensional structure.
• L-histidine monohydrochloride monohydrate — buffer component.
• Polysorbate 80 — a surfactant that prevents protein aggregation and adherence to vial or syringe surfaces. Polysorbates can occasionally cause allergic reactions; tell your doctor if you have a known polysorbate allergy.
• Sucrose — a stabiliser that protects the protein during storage.
• Water for injections — the solvent.

Presentations

Pyzchiva 45 mg is supplied as a solution for subcutaneous injection in a single-use glass vial containing 45 mg of ustekinumab in 0.5 mL of solution. A 90 mg subcutaneous strength is also available in some jurisdictions, typically as a prefilled syringe. A 130 mg intravenous presentation (in a single-dose vial, to be diluted before infusion) is used for the induction phase in Crohn's disease and ulcerative colitis. Not all strengths and pack sizes may be available in every country.

Appearance

Pyzchiva solution for injection is clear to slightly opalescent (having a faint pearlescent sheen) and colourless to light yellow. A small number of translucent protein particles may be present, which is normal for monoclonal antibody products and does not affect efficacy or safety.

Marketing Authorisation Holder and Manufacturer

Pyzchiva was developed by Samsung Bioepis and is marketed by Samsung Bioepis NL B.V. in the European Union, with commercial partnerships in several regions (for example, distribution in Europe in collaboration with Sandoz). It is manufactured in facilities complying with current Good Manufacturing Practice (GMP) standards and is approved by the European Medicines Agency (EMA) and other regulatory authorities, including the U.S. Food and Drug Administration (FDA). Several other ustekinumab biosimilars have also been approved worldwide, increasing the availability and affordability of IL-12/23 inhibitor therapy.

References

1. European Medicines Agency (EMA). Pyzchiva (ustekinumab) — European Public Assessment Report and Summary of Product Characteristics. 2024. Available at: ema.europa.eu/EPAR/pyzchiva
2. European Medicines Agency (EMA). STELARA (ustekinumab) — Summary of Product Characteristics (reference product).
3. U.S. Food and Drug Administration (FDA). Purple Book: Database of Licensed Biological Products — Ustekinumab biosimilars. Available at: purplebooksearch.fda.gov
4. Papp KA, Lebwohl MG, Puig L, et al. A randomized, double-blind, comparative Phase 3 trial of the ustekinumab biosimilar SB17 versus reference ustekinumab in patients with moderate to severe plaque psoriasis. Published in a peer-reviewed dermatology journal, 2024.
5. Leonardi CL, Kimball AB, Papp KA, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet. 2008;371(9625):1665-1674. doi:10.1016/S0140-6736(08)60725-4
6. Feagan BG, Sandborn WJ, Gasink C, et al. Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease (UNITI-1, UNITI-2, IM-UNITI). N Engl J Med. 2016;375(20):1946-1960. doi:10.1056/NEJMoa1602773
7. Sands BE, Sandborn WJ, Panaccione R, et al. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis (UNIFI). N Engl J Med. 2019;381(13):1201-1214. doi:10.1056/NEJMoa1900750
8. National Institute for Health and Care Excellence (NICE). Ustekinumab for treating active psoriatic arthritis. Technology appraisal guidance [TA340]. 2015.
9. British National Formulary (BNF). Ustekinumab. Available at: bnf.nice.org.uk/drugs/ustekinumab
10. European Medicines Agency (EMA). Biosimilars in the EU — Information guide for healthcare professionals. Revised 2019 (periodically updated). Available at: ema.europa.eu
11. World Health Organization (WHO). WHO Model List of Essential Medicines — 23rd List, 2023.

Editorial Team

Sources: European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), National Institute for Health and Care Excellence (NICE), British National Formulary (BNF), World Health Organization (WHO), and peer-reviewed clinical trials. All content is independent of commercial funding or pharmaceutical industry influence.