PYZCHIVA becomes Samsung Bioepis’ fifth biosimilar and third immunology biosimilar to be launched in the US
Samsung Bioepis Co., Ltd. announced that PYZCHIVA® (ustekinumab-ttwe), a biosimilar to Stelara (ustekinumab), is now available in the United States. PYZCHIVA has been approved for the treatment of moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis. Through Samsung Bioepis’ commercialization partner Sandoz, PYZCHIVA is available to patients across US starting today in 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.
“The launch of PYZCHIVA is a significant milestone for both Samsung Bioepis and for millions of patients living with inflammatory conditions in the US. 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. “We remain steadfast in our commitment to serve patients in need through our continued innovation to make medicine more accessible.”
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About PYZCHIVA® (ustekinumab-ttwe) injection, for subcutaneous (45 mg/0.5 mL and 90 mg/mL) or intravenous (130 mg/26 mL solution) use
PYZCHIVA (ustekinumab-ttwe) is indicated for:
- 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.
Source: Businesswire