Alvotech and Teva Launch Selarsdi (Biosimilar, Stelara) in the US
Shots:
- Alvotech and Teva have launched Selarsdi (ustekinumab-aekn) injection, a biosimilar to Stelara, to treat psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis, and pediatric psoriatic arthritis across the US
- The FDA has provisionally determined that all Selarsdi presentations can be approved as interchangeable with Stelara after exclusivity expires on Apr 30, 2025. The four approved presentations are 45 mg/0.5 mL & 90 mg/mL prefilled SC syringes, 45 mg/0.5 mL single-dose vials for SC, and 130 mg/26 mL single-dose IV infusion vials
- In August 2020, Teva and Alvotech formed a partnership to commercialize five Alvotech biosimilars exclusively in the US. Alvotech handles development & manufacturing, while Teva manages commercialization
Ref: Alvotech | Image: Alvotech & Teva
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