Get support services for your patients and your practice through Sandoz One Source
Services for Patients
Our team is here to help at every step, from the first dose through the continuation of therapy
PYZCHIVA® Co-pay Card
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Co-pay offer as low as $0 for eligible, commercially insured patients. Terms and conditions applya
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Providers can enroll patients online, or patients can enroll themselves online or over the phone
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Instant access means cards are available immediately for those who qualify
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No expiration, with automatic annual reset of card benefits
PYZCHIVA Co-pay Terms and Conditions: Limitations apply. Valid only for those with private commercial insurance. Prescription must be for an approved indication. Restrictions, including monthly and/or annual maximums may apply. Patient is responsible for any costs once program limit is reached. Program not valid (i) if prescription for PYZCHIVA is paid, in whole or in part, under Medicare (including Part D, even in the coverage gap), Medicaid, Medigap, TRICARE, VA, DoD, or any other federal or state health care program, (ii) where patient is not using insurance coverage at all, (iii) where the patient's insurance plan reimburses for the entire cost of the drug, or (iv) where product is not covered by patient's insurance. The value of this program is exclusively for the benefit of patients and is intended to be credited towards patient out-of-pocket obligations and maximums, including applicable co-payments, coinsurance, and deductibles. It is a violation of the terms and conditions of this program to use it to enroll patients for the purposes of a copay accumulator or maximizer program. Sandoz reserves the right to take any appropriate action against any person or entity using the program in violation of the terms and conditions. Program is not valid where prohibited by law. Patient may not seek reimbursement for the value received from this program from other parties, including any health insurance program or plan, flexible spending account, or health care savings account. Patient is responsible for complying with any applicable limitations and requirements of their health plan related to the use of the Program. Valid only in the United States and US Territories (Puerto Rico, Guam, Northern Mariana Islands, and Virgin Islands). This Program is not health insurance. Program may not be combined with any third-party rebate, coupon, or offer. Proof of purchase may be required. Co-pay program has no cash value. Additional terms and conditions may apply. Sandoz reserves the right to rescind, revoke, or amend the Program and discontinue support at any time without notice.
Case Managers
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Provide education about PYZCHIVA
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Help identify opportunities for savings
Injection support
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Personalized, 1:1 training options available
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Nurse support to answer questionsa
Insurance support
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Assistance for patients in:
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Navigating and understanding their health plan benefits
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Identifying a pharmacy that will ship their medication
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aNurses cannot provide medical advice. Patients should consult with their doctor on questions about therapy and disease.
Services for Practices
Reimbursement Support
Sandoz One Source Case Managers provide expert assistance with processes for approval and reimbursement, including benefits verification and investigation as well as billing and coding support.
3 ways to enroll:
Complete the online Sandoz One Source Enrollment form for ADULT patients or PEDIATRIC patients
Download the Sandoz One Source Enrollment Form for ADULT patients or PEDIATRIC patients and fax the completed form to 1-844-422-5957
Call 1-855-SANDOZ-8 (1-855-726-3698) to speak with a live Sandoz One Source Case Manager
PATIENT AUTHORIZATION FORM FOR PYZCHIVA
If your patient has not completed the Patient Authorization Form for PYZCHIVA, direct them to the online form OR download the form here and fax a completed copy to Sandoz One Source at 1-844-422-5957.
Frequently Asked Questions
PYZCHIVA is the ustekinumab biosimilar from Sandoz, a global leader with more than 25 years of experience in biosimilar medications.1 PYZCHIVA is indicated to treat all the same inflammatory conditions as Stelara®.2 Please see full Indications for PYZCHIVA below.
A Phase 3 confirmatory study showed that patients can expect the same safety and efficacy results when switching from Stelara® to PYZCHIVA.3 Presentations include a prefilled syringe, a vial for subcutaneous injection, and a vial for intravenous infusion (loading dose for Crohn’s and ulcerative colitis patients only).2
Biosimilars such as PYZCHIVA go through a rigorous evaluation process in order to demonstrate to the FDA that they have no clinically meaningful differences from their reference product when it comes to quality, safety, and efficacy.4
A Phase 3 confirmatory switch study showed that patients can expect the same safety and efficacy when switching from Stelara® to PYZCHIVA. The study also showed that rates of anti-drug antibodies were lower for PYZCHIVA than for Stelara® (13.3% vs 39.4%, respectively) up to Week 28.3
PYZCHIVA provides what you and your patients have come to expect from ustekinumab in terms of results and support.
PYZCHIVA offers:
- The same results: A clinical study showed that patients can expect the same efficacy and safety with PYZCHIVA that they have experienced with Stelara®3
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Dosing options you’re familiar with: The presentations that are available from PYZCHIVA make for a seamless switch
- Sandoz One Source support services: Support for both switch and new start patients, as well as office staff
- Financial Support: Co-pay as low as $0 for eligible patients. Terms and conditions applya
- An unparalleled heritage in biosimilars: Sandoz has been an industry leader in biosimilar medications for more than 25 years1
There will likely be a choice between at least 2 ustekinumab biosimilars covered by a patient’s insurance. There are a number of important factors to consider when making your choice.
PYZCHIVA offers:
- The same results: A clinical study showed that patients can expect the same efficacy and safety with PYZCHIVA that they have experienced with Stelara®
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Dosing options you’re familiar with: The presentations that are available from PYZCHIVA make for a seamless switch
- Sandoz One Source support services: Support for both switch and new start patients, as well as office staff
- Financial Support: Co-pay as low as $0 for eligible patients. Terms and conditions applya
- An unparalleled heritage in biosimilars: Sandoz has been an industry leader in biosimilar medications for more than 25 years1
Sandoz is pleased to offer a Co-pay Program for eligible, commercially insured patients who are prescribed PYZCHIVA. Qualifying patients may pay as little as $0 per treatment. Terms and conditions apply.a
- Cards are available immediately for those who qualify, and there is no expiration, with automatic annual reset of card benefits.
- Providers can enroll patients in the co-pay program online, or patients can enroll themselves online or over the phone.
If your patient does not qualify for the Co-pay Program, Sandoz One Source may be able to connect them to other opportunities for financial support.
A biosimilar is a biologic medication that is highly similar to and has no clinically meaningful differences from an existing FDA-approved biologic, called a reference product.4 Biosimilars are rigorously evaluated by the FDA to show that there are no clinically meaningful differences in safety, efficacy, or quality between the biosimilar and the reference product.4
While biologics have transformed the lives of millions of people suffering from debilitating conditions, they come with a high price tag. Biosimilars offer comparable efficacy and safety to their reference products and increase access by reducing costs.5
Prescribing biosimilars has resulted in:
- $36 billion in savings since 20155
- $12.4 billion in savings in 2023 alone5
- 495 million additional patient days of treatment5
- ~45% lower out of pocket costs for patients who used certain biosimilars instead of reference products6
Extrapolation is part of the FDA-approval process in which a biosimilar is approved for an indication or indications that it was not directly studied in. If the totality of evidence demonstrates biosimilarity to the reference biologic in 1 indication, the manufacturer may then apply for the approval of additional indications.7
To do so, the manufacturer must work with the FDA to determine what data are needed to support extrapolations. Typically, the manufacturer must provide scientific justification, including knowledge about the MOA, PK, PD, efficacy, safety, and immunogenicity of the reference product in each of its approved indications.7
The practice of extrapolation is critical for biosimilars since, unlike reference biologics, biosimilars are approved by the FDA through an abbreviated pathway. This is what allows the opportunity for biosimilars to be more cost effective and accessible than reference products.7
A seamless switch
Having dosing options that you’re familiar with makes for a less complicated switch to PYZCHIVA.
Review dosing options
Proven the same
The Phase 3 clinical trial showed the same efficacy and safety between PYZCHIVA and Stelara®.
Explore the dataImportant Safety Information and Indications
INDICATIONS
PYZCHIVA® (ustekinumab-ttwe) is indicated for the
treatment of:
- patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
- patients 6 years or older with active psoriatic arthritis
- adult patients with moderately to severely active Crohn’s disease
- adult patients with moderately to severely active ulcerative colitis
Important Safety Information
CONTRAINDICATIONS
PYZCHIVA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in PYZCHIVA.
Warnings and Precautions
Infections
Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections requiring hospitalization or otherwise clinically significant infections were reported. In patients with plaque psoriasis, these included diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, and urinary tract infections. In patients with psoriatic arthritis, this included cholecystitis. In patients with Crohn’s disease, these included anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and Listeria meningitis. In patients with ulcerative colitis, these included gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis.
Avoid initiating treatment with PYZCHIVA 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 PYZCHIVA in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with PYZCHIVA and discontinue PYZCHIVA for serious or clinically significant infections until the infection resolves or is adequately treated.
Theoretical Risk for Vulnerability to Particular Infections
Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria, Salmonella, and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with ustekinumab products may be susceptible to these types of infections. Consider appropriate diagnostic testing (e.g., tissue culture, stool culture as dictated by clinical circumstances).
Pre-treatment Evaluation for Tuberculosis (TB)
Evaluate patients for TB infection prior to initiating treatment with PYZCHIVA. Avoid administering PYZCHIVA to patients with active TB infection. Initiate treatment of latent TB prior to administering PYZCHIVA. Closely monitor patients receiving PYZCHIVA for signs and symptoms of active TB during and after treatment.
Malignancies
Ustekinumab products are immunosuppressants and may increase the risk of malignancy. Malignancies were reported among patients who received ustekinumab in clinical trials. 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 reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had risk factors for developing non‑melanoma skin cancer. Monitor all patients receiving PYZCHIVA, especially those greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy, and those with a history of PUVA treatment, for the appearance of 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 PYZCHIVA.
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 post-marketing 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 PYZCHIVA for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue PYZCHIVA.
Immunizations
Prior to initiating therapy with PYZCHIVA, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with PYZCHIVA should avoid receiving live vaccines. Avoid administering BCG vaccines during treatment, 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 PYZCHIVA products due to the potential risk of shedding from the household contact and transmission to patient. Non-live vaccinations received during a course of PYZCHIVA 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. Patients improved with discontinuation of therapy and in certain cases administration of corticosteroids. If diagnosis is confirmed, discontinue PYZCHIVA and institute appropriate treatment.
Allergen 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.
MOST COMMON ADVERSE REACTIONS
The most common adverse reactions (≥3% and higher than that with placebo) in adults from plaque psoriasis clinical trials for ustekinumab 45 mg, ustekinumab 90 mg, or placebo were nasopharyngitis (8%, 7%, 8%), upper respiratory tract infection (5%, 4%, 5%), headache (5%, 5%, 3%), and fatigue (3%, 3%, 2%), respectively. The safety profile in pediatric subjects was similar to the safety profile from studies in adults with plaque psoriasis. In psoriatic arthritis (PsA) clinical trials, a higher incidence of arthralgia and nausea was observed in ustekinumab-treated patients when compared with placebo-treated patients (3% vs 1% for both). In the Crohn’s disease induction trials, common adverse reactions (≥3% of patients treated with ustekinumab and higher than placebo) reported through Week 8 for ustekinumab 6 mg/kg intravenous single infusion or placebo included: vomiting (4% vs 3%). In the Crohn’s disease maintenance trial, common adverse reactions (≥3% of patients treated with ustekinumab and higher than placebo) reported through Week 44 for ustekinumab 90 mg subcutaneous injection or placebo were nasopharyngitis (11% vs 8%), injection site erythema (5% vs 0%), vulvovaginal candidiasis/mycotic infection (5% vs 1%), bronchitis (5% vs 3%), pruritus (4% vs 2%), urinary tract infection (4% vs 2%), and sinusitis (3% vs 2%). In the ulcerative colitis induction trial, common adverse reactions (≥3% of patients treated with ustekinumab and higher than placebo) reported through Week 8 for ustekinumab 6 mg/kg intravenous single infusion or placebo included nasopharyngitis (7% vs 4%). In the ulcerative colitis maintenance trial, common adverse reactions (≥3% of patients treated with ustekinumab and higher than placebo) reported through Week 44 for ustekinumab 90 mg subcutaneous injection or placebo were nasopharyngitis (24% vs 20%), headache (10% vs 4%), abdominal pain (7% vs 3%), influenza (6% vs 5%), fever (5% vs 4%), diarrhea (4% vs 1%), sinusitis (4% vs 1%), fatigue (4% vs 2%), and nausea (3% vs 2%).
Provide the Medication Guide to your patients and encourage discussion.
Please see full Prescribing Information for PYZCHIVA.
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
References: 1. Sandoz website. Accessed February 5, 2025. https://www.sandoz.com 2. PYZCHIVA. Prescribing Information. Sandoz Inc; 2024. 3. Feldman SR, Narbutt J, Girolomoni G, et al. A randomized, double-blind, phase III study assessing clinical similarity of SB17 (proposed ustekinumab biosimilar) to reference ustekinumab in subjects with moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2024;91:440-447. doi:10.1016/j.jaad.2024.04.045 4. US Food and Drug Administration. Biosimilar Regulatory Review and Approval. Updated December 13, 2022. Accessed February 5, 2025. https://www.fda.gov/media/151061/download?attachment 5. Association for Accessible Medicines. The U.S. Generic & Biosimilar Medicines Savings Report. September 2024. Accessed February 5, 2025. https://www.accessiblemeds.org/sites/default/files/2024-09/AAM-2024-Generic-Biosimilar-Medicines-Savings-Report.pdf 6. Socal M, Ballreich J, Chyr L, Anderson G. Biosimilar medications – Savings opportunities for large employers. Johns Hopkins Bloomberg School of Public Health, Department of Health Policy and Management; 2020. Accessed February 5, 2025. https://www.eric.org/wp-content/uploads/2020/03/JHU_Savings-Opportunities-for-Large-Employers.pdf 7. US Food and Drug Administration. Biosimilar Product Regulatory Review and Approval. Accessed February 5, 2025. https://www.fda.gov/files/drugs/published/Biosimilar-Product-Regulatory-Review-and-Approval.pdf
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