Alvotech and Teva Launch Selarsdi (Biosimilar, Stelara) in the US
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- 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
Related News:- Alvotech and Teva Report the Regulatory Filing Acceptance for AVT06 (Biosimilar, Eylea) Across the US
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
