Alvotech(US:ALVO) GlobeNewswire News Room·2024-10-22 11:00Core Viewpoint - The FDA has approved SELARSDI (ustekinumab-aekn) in a new intravenous formulation, expanding its indications to include treatment for adults with Crohn's disease and ulcerative colitis, with a U.S. launch expected in Q1 2025 [1][2] Group 1: Product Approval and Launch - SELARSDI 130 mg/26 mL has been approved for intravenous infusion, aligning its label with the reference product Stelara® [1] - The U.S. launch of SELARSDI for all indications is anticipated in the first quarter of 2025 [1] - Previous approvals include SELARSDI 45 mg/0.5 mL and 90 mg/mL for subcutaneous injection, approved in April 2024 for moderate to severe plaque psoriasis and active psoriatic arthritis [2] Group 2: Company Statements and Strategic Goals - Alvotech's CEO expressed commitment to aligning SELARSDI's label with the reference product before the launch, highlighting successful launches in Canada, Japan, and Europe [2] - Teva's Senior VP noted the expansion of SELARSDI's indications as a significant milestone in increasing access to biosimilars in the U.S. [2] - The partnership between Alvotech and Teva has expanded to include nine products, with a focus on increasing the availability of biosimilars [4] Group 3: Product Development and Technology - Alvotech developed SELARSDI using Sp2/0 cells and a continuous perfusion process, similar to the production of Stelara [3] - Ustekinumab, the active ingredient in SELARSDI, targets the p40 protein, crucial for treating immune-mediated diseases [3][6] Group 4: Market Context and Competitive Landscape - Alvotech aims to be a global leader in the biosimilar market, with a pipeline that includes nine candidates targeting various diseases [8] - The strategic partnership with Teva leverages their extensive sales and marketing infrastructure for commercialization in the U.S. [4][10]