Alvotech(US:ALVO) Newsfilter·2024-04-16 21:30Core Insights - The FDA has approved SELARSDI (ustekinumab-aekn) as a biosimilar to Stelara for treating moderate to severe plaque psoriasis and active psoriatic arthritis in both adults and pediatric patients aged 6 years and older [1][2][10] - SELARSDI is expected to be marketed in the U.S. on or after February 21, 2025, following a settlement agreement with Johnson & Johnson [1][3] - The approval of SELARSDI marks the second biosimilar approved under the strategic partnership between Alvotech and Teva, with Teva responsible for its exclusive commercialization in the U.S. [1][4] Company Overview - Alvotech is a biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a global leader in the biosimilar space [8] - Teva Pharmaceutical Industries Ltd. is a global pharmaceutical leader with a strong portfolio, leveraging generics expertise and innovation [9] Market Context - Sales of the reference product Stelara in the U.S. were nearly $7 billion in 2023, indicating significant market potential for SELARSDI [3] - The biosimilars market is growing globally and in the U.S., with biosimilars being a key component of Teva's Pivot to Growth strategy [2] Development and Approval Process - The FDA approval of SELARSDI was based on a comprehensive clinical development program, including studies that demonstrated equivalent efficacy and safety compared to Stelara [5][6] - The development utilized a purpose-built end-to-end platform for biosimilars, employing the same cell type and continuous perfusion process as the reference product [2][5] Strategic Partnership - The strategic partnership between Alvotech and Teva was established in August 2020 for the exclusive commercialization of multiple biosimilar candidates, with recent expansions to include additional products [4] - This partnership allows Teva to leverage its extensive sales and marketing infrastructure to bring biosimilars to market effectively [4]