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Alvotech and Teva Secure U.S. License Date for AVT04, a Proposed Biosimilar to Stelara®
According to the settlement agreement, AVT04 (ustekinumab) can be marketed in the US, subject to regulatory approval, no later than February 21, 2025 Alvotech
About this update from Alvotech
[{"type":"text","content":"According to the settlement agreement, AVT04 (ustekinumab) can be marketed in the US, subject to regulatory approval, no later than February 21, 2025 Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced they have reached a settlement and license agreement with Johnson & Johnson (NYSE:JNJ) concerning AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab) in the United States. The settlement grants a license entry date for AVT04 in the United States no later than February 21, 2025. “We are delighted to have secured a U.S. license date for our second biosimilar candidate in the U.S. and I believe this exemplifies our multi-product approach to biosimilars globally,” said Robert Wessman, Chairman and CEO of Alvotech. “Biosimilars are a key component of Teva’s short and long-term strategy,” said Sven Dethlefs, PhD, Executive Vice President, North America Commercial at Teva, “Today’s announcement is another step forward in our partnership with Alvotech, who shares our commitment to lower the cost burden of biologics on the healthcare system.” About AVT04 (ustekinumab)AVT04 is a monoclonal antibody and a biosimilar candidate to Stelara® (ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses [1]. AVT04 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed. Stelara is a registered trademark of Johnson & Johnson. [1] https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf About AlvotechAlvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disease, osteoporosis, respiratory di...