PETAH TIKVA (dpa-AFX) - Alvotech (ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), announced the FDA has approved SELARSDI in a new presentation, 130 mg/26 mL solution in a single-dose vial for intravenous infusion. The approval paves the way for SELARSDI to further align its label with the indications of the reference product Stelara in the U.S. at launch, which is expected in the first quarter of 2025.
Thomas Rainey, Senior Vice President, U.S. Biosimilars, said: 'This development allows us to serve patients battling gastrointestinal diseases as the U.S. launch of SELARSDI approaches in early 2025.'
In August 2020, Alvotech and Teva entered into a strategic partnership for the commercialization of five of Alvotech's biosimilar product candidates, including SELARSDI.
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