PYZCHIVA: A New Biosimilar for Inflammatory Conditions

PYZCHIVA becomes Samsung Bioepis’ fifth biosimilar and third immunology biosimilar to be launched in the U.S. The drug is commercialized by Sandoz and is available in three different strengths: 45 mg/0.5 mL and 90 mg/mL pre-filled syringes, 130 mg/26 mL intravenous infusion single-dose vial, and 45 mg/0.5 mL subcutaneous vials.

Expanded Treatment Options and Cost Savings

PYZCHIVA is approved for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis. The launch of PYZCHIVA is expected to offer expanded treatment options, potentially reducing healthcare costs and contributing to a more sustainable healthcare system.

“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 would allow for reduced healthcare costs, ultimately contributing to a more sustainable healthcare system,” said Linda Y. MacDonald, Executive Vice President and Head of Global Commercial Division at Samsung Bioepis.

Linda Y. MacDonald

Commercialization Agreement and License Period

Samsung Bioepis and Sandoz entered into a commercialization agreement for PYZCHIVA in September 2023. Samsung Bioepis remains responsible for development, registration, intellectual property, manufacturing, and supply. The license period for PYZCHIVA will begin on February 22, 2025, according to the settlement and license agreement between Samsung Bioepis and Janssen Biotech Inc.

Biosimilar Pipeline and Market Impact

Samsung Bioepis has a total of 11 biosimilars in its products and pipeline portfolio across various therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. Currently, Samsung Bioepis has 10 biosimilars approved in the U.S. and five commercially available.

About PYZCHIVA® (ustekinumab-ttwe) Injection

PYZCHIVA (ustekinumab-ttwe) is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis.

• Plaque Psoriasis: PYZCHIVA 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.
• Psoriatic Arthritis: PYZCHIVA is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis.
• Crohn’s Disease: PYZCHIVA is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease.
• Ulcerative Colitis: PYZCHIVA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

Safety Information and Precautions

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

Patients should be evaluated for tuberculosis infection prior to initiating treatment with PYZCHIVA. Avoid administering PYZCHIVA to patients with active tuberculosis infection. Initiate treatment of latent tuberculosis prior to administering PYZCHIVA. Consider anti-tuberculosis therapy prior to initiation of PYZCHIVA in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.

Ustekinumab products are immunosuppressants and may increase the risk of malignancy. Malignancies were reported among subjects who received ustekinumab in clinical studies. In rodent models, inhibition of IL-12/IL-23 increased the risk of malignancy.

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.

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. Patients recovered with supportive care following withdrawal of ustekinumab products.

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 with PYZCHIVA 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 because of the potential risk for shedding from the household contact and transmission to the patient.

Non-live vaccinations received during a course of PYZCHIVA may not elicit an immune response sufficient to prevent disease.

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.

Common Adverse Reactions

Most common adverse reactions are:

• Psoriasis (≥3%): nasopharyngitis, upper respiratory tract infection, headache, and fatigue.
• Crohn’s Disease, induction (≥3%): vomiting.
• Crohn’s Disease, maintenance (≥3%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis.
• Ulcerative colitis, induction (≥3%): nasopharyngitis.
• Ulcerative colitis, maintenance (≥3%): nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology.

Media Contact

Yoon Kim, yoon1.kim@samsung.com
Anna nayun Kim, nayun86.kim@samsung.com