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Alvotech and Teva Reports the US FDA’s Approval for the Additional Presentation of Selarsdi (Biosimilar, Stelara)

Shots: 

  • Alvotech and Teva have received the US FDA’s approval of Selarsdi’s new dosing presentation of 130mg/26mL (5mg/mL) solution in a single-dose vial for IV infusion for the same indications as Stelara (ustekinumab). It will be launched in the US during Q1’25 
  • The US FDA, in Apr 2024, approved Selarsdi’s dosing of 45mg/0.5mL & 90mg/mL injection in a prefilled SC syringe to treat moderate to severe plaque psoriasis & active psoriatic arthritis among adults and pediatric (≥6yrs.) 
  • Both companies have entered into a settlement & license agreement with J&J (Stelara’s manufacturer) in Jun 2023 to market Selarsdi across the US in Feb 2025 

Ref: Alvotech and Teva   | Image: Alvotech and Teva | Press Release

Related News:- Meitheal Pharmaceuticals Receives Exclusive Commercial Rights of Three Biosimilars Across the US 

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