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: Teva | Image: Alvotech
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
