Pharma Focus America

Alvotech and Teva Strike Deal to Introduce Avt04, a Biotech Equivalent of Stelara®, in the Us

Monday, June 12, 2023

Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals Inc., a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), have recently announced a significant agreement with Johnson & Johnson (NASDAQ: JNJ). According to the agreement, Alvotech and Teva have obtained the rights to commercialize AVT04, a proposed biosimilar to Stelara® (ustekinumab), in the United States. The sales of AVT04 in the United States will commence no later than February 21, 2025.

Róbert Wessman, Chairman and CEO of Alvotech, expressed excitement about the authorization and marketing start date for AVT04 in the United States. He emphasized the benefits of simultaneously developing multiple drugs for global markets, citing this achievement as an example. Sven Dethlefs, the chief commercial officer for Teva in North America, stated that biopharmaceutical analogs are a key focus for Teva in both the short and long term. The agreement marks a significant step in their partnership with Alvotech, as both companies are committed to reducing the high costs associated with biotech medicines in the healthcare system.

AVT04 (ustekinumab) is a monoclonal antibody and a biotech analog of Stelara®. It targets the IL-12 and IL-23 cytokines in the immune system, which are involved in certain immune-mediated diseases. However, it is important to note that AVT04 is currently in the development stage and has not yet received approval for use in any market. The regulatory authorities have not provided a final decision on the use of AVT04 as a biotech drug analog.

https://www.globenewswire.com/news-release/2023/06/12/2685977/0/is/Alvotech-og-Teva-n%C3%A1-samningi-um-upphafsdag-s%C3%B6lu-%C3%A1-AVT04-l%C3%ADft%C3%A6knilyfjahli%C3%B0st%C3%A6%C3%B0u-vi%C3%B0-Stelara-%C3%AD-Bandar%C3%ADkjunum.html

ROUQETTE - Pharma Virtual LabSino Biological || Baculovirus - Insect Cell Expression Platform