Samsung Bioepis Co., Ltd. has announced the official U.S. launch of PYZCHIVA® (ustekinumab-ttwe), a biosimilar to Stelara (ustekinumab), expanding treatment options for patients with inflammatory conditions. This development marks a significant milestone in the biosimilars market and further solidifies Samsung Bioepis’ role in increasing accessibility to biologic medicines.
Availability and Indications
PYZCHIVA is now commercially available in the United States through Samsung Bioepis’ commercialization partner, Sandoz. The biosimilar has been approved for the treatment of:
- Moderate to severe plaque psoriasis in adults and pediatric patients aged six years and older who are candidates for phototherapy or systemic therapy.
- Active psoriatic arthritis in adults and pediatric patients aged six years and older.
- Moderately to severely active Crohn’s disease in adult patients.
- Moderately to severely active ulcerative colitis in adult patients.
To cater to various patient needs, PYZCHIVA is available in multiple formulations, including:
- 45 mg/0.5 mL and 90 mg/mL pre-filled syringes.
- 130 mg/26 mL intravenous infusion single-dose vial.
- 45 mg/0.5 mL subcutaneous vials.
Commitment to Accessible Biologic Medicines
Linda Y. MacDonald, Executive Vice President and Head of Global Commercial Division at Samsung Bioepis, emphasized the company’s commitment to making medicines more accessible. “The launch of PYZCHIVA is a significant milestone for both Samsung Bioepis and for millions of patients living with inflammatory conditions in the U.S. The expanded treatment options in the market allow for reduced healthcare costs, ultimately contributing to a more sustainable healthcare system. We remain steadfast in our commitment to serve patients in need through continued innovation.”
Strategic Partnership with Sandoz
Samsung Bioepis and Sandoz entered into a commercialization agreement for PYZCHIVA in September 2023. Under this agreement, Samsung Bioepis retains responsibility for product development, regulatory registration, intellectual property management, manufacturing, and supply. In the U.S., the license period for PYZCHIVA will commence on February 22, 2025, per the terms of a settlement and license agreement with Janssen Biotech Inc.
Samsung Bioepis’ Growing Biosimilars Portfolio
Samsung Bioepis has been at the forefront of biosimilar development, with a robust pipeline spanning multiple therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. To date, the company has secured 10 biosimilar approvals in the U.S., with five already commercially available.
Important Safety Information
While PYZCHIVA provides an alternative for patients requiring ustekinumab treatment, it is essential to understand its safety profile and associated risks.
Contraindications
PYZCHIVA is contraindicated in patients with a known hypersensitivity to ustekinumab products or any of the excipients in the formulation.
Warnings and Precautions
Risk of Infections
Like other ustekinumab products, PYZCHIVA may increase the risk of infections, including serious bacterial, mycobacterial, fungal, and viral infections. In clinical trials, the following serious infections were observed:
- 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.
Patients with active infections should not initiate PYZCHIVA treatment until the infection resolves. Additionally, caution should be exercised in patients with a history of recurrent infections.
Potential for Increased Vulnerability to Certain Infections
Individuals with genetic deficiencies in IL-12/IL-23 signaling may be particularly vulnerable to infections from mycobacteria, salmonella, and Bacillus Calmette-Guérin (BCG) vaccination. Although the full implications of IL-12/IL-23 blockade in patients receiving ustekinumab products remain unknown, diagnostic testing may be appropriate in certain cases.
Tuberculosis Screening and Treatment
All patients should be screened for tuberculosis before initiating PYZCHIVA. Treatment of latent tuberculosis should be completed before starting therapy, and patients with a history of tuberculosis should be closely monitored for reactivation.
Malignancy Risk
As an immunosuppressant, ustekinumab products may elevate the risk of malignancy. Cases of non-melanoma skin cancer have been reported in post-marketing surveillance, particularly in patients with additional risk factors such as prolonged immunosuppressant use or previous PUVA therapy. Regular skin examinations are recommended for all patients undergoing PYZCHIVA treatment.
Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. Patients experiencing severe allergic reactions should discontinue PYZCHIVA immediately and seek appropriate medical treatment.
Posterior Reversible Encephalopathy Syndrome (PRES)
Although rare, cases of PRES have been observed in clinical trials and post-marketing reports. Symptoms may include headaches, seizures, confusion, and visual disturbances. If PRES is suspected, treatment with PYZCHIVA should be discontinued.
Immunization Considerations
Patients should receive all age-appropriate immunizations before starting PYZCHIVA. Live vaccines should be avoided during treatment, and BCG vaccines should not be administered for one year before or after therapy. Non-live vaccines administered during PYZCHIVA treatment may not elicit a sufficient immune response.
Noninfectious Pneumonia
Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported with ustekinumab products. Patients presenting with respiratory symptoms such as cough or dyspnea should be evaluated, and therapy should be discontinued if necessary.
Common Adverse Reactions
The most commonly reported adverse reactions in clinical studies include:
- Psoriasis (≥3% incidence): Nasopharyngitis, upper respiratory tract infections, headache, and fatigue.
- Crohn’s Disease (induction phase, ≥3% incidence): Vomiting.
- Crohn’s Disease (maintenance phase, ≥3% incidence): Nasopharyngitis, injection site erythema, vulvovaginal candidiasis, bronchitis, pruritus, urinary tract infections, and sinusitis.
- Ulcerative Colitis (induction phase, ≥3% incidence): Nasopharyngitis.
- Ulcerative Colitis (maintenance phase, ≥3% incidence): Nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea.
