Sandoz has received FDA approval for Pyzchiva® (ustekinumab-ttwe), a biosimilar developed by Samsung Bioepis Co., Ltd. The approval includes formulations for subcutaneous injection (45 mg/0.5 mL and 90 mg/mL pre-filled syringes) and intravenous infusion (130 mg/26 mL single-dose vial). Pyzchiva® will be launched in the US by February 2025 under a settlement and license agreement with Janssen Biotech Inc.

Pyzchiva® is approved for all indications of its reference medicine, Stelara® (ustekinumab), encompassing treatments for moderate to severe plaque psoriasis, active psoriatic arthritis, Crohn’s disease, ulcerative colitis in adults, and specific conditions in pediatric patients. This approval marks Pyzchiva® as one of the initial biosimilars of ustekinumab entering the US market.

Claire D'Abreu-Hayling, Sandoz's Chief Scientific Officer, highlighted the company's commitment to expanding access to high-quality immunology treatments through affordable biosimilars. This approval is a significant step in Sandoz's strategy to grow its immunology portfolio in the US.

Pyzchiva® was approved based on robust clinical studies demonstrating its equivalent efficacy and safety compared to its reference medicine. Under its agreement with Samsung Bioepis, Sandoz has rights to market Pyzchiva® in the US, Canada, the European Economic Area (EEA), Switzerland, and the UK, with Samsung Bioepis handling development, registration, intellectual property, manufacturing, and supply.

The approval of Pyzchiva® underscores Sandoz's commitment to enhancing patient access to essential therapies, particularly in chronic conditions such as psoriasis and psoriatic arthritis, where treatment affordability is crucial for long-term management.

 

Source: globenewswire.com

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