NEW BRUNSWICK (dpa-AFX) - Sandoz Group AG (SDZNY), a Swiss maker of generic and biosimilar medicines, announced Monday that the US Food and Drug Administration has approved biosimilar Pyzchiva (ustekinumab-ttwe), developed by Samsung Bioepis Co., Ltd, for all indications of its reference medicine Stelara (ustekinumab) of Johnson & Johnson (JNJ).
Pyzchiva is indicated to treat patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, as well as with active psoriatic arthritis. The medicine is also indicated for adult patients with moderately to severely active Crohn's disease, and adult patients with moderately to severely active ulcerative colitis.
The 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection and 130 mg/26 mL (5 mg/mL) single-dose vial for intravenous infusion will be commercialized by Sandoz in the US.
In addition, the FDA provisionally determined that Pyzchiva would be interchangeable with the reference medicine as it is currently subject to an unexpired period of exclusivity for the first interchangeable biosimilar biological products.
Sandoz said it intends to launch Pyzchiva in the US in February 2025, in accordance with the settlement and license agreement with Janssen Biotech Inc. previously announced by Samsung Bioepis.
Pyzchiva is expected to be among the first wave of ustekinumab biosimilars to launch in the US.
Sandoz added that Pyzchiva is a key biosimilar value driver for the company over the mid-term. The approval is a major step in advancing the Sandoz growth strategy by extending the US immunology portfolio.
Sandoz entered into a development and commercialization agreement for biosimilar ustekinumab with Samsung Bioepis in September 2023. Under the deal terms, Sandoz has the right to commercialize Pyzchiva in the US, Canada, the European Economic Area, Switzerland and the UK.
Samsung Bioepis remains responsible for development, registration, intellectual property, manufacturing and supply.
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