Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Applications for AVT05, a Proposed Biosimilar to Simponi® and Simponi Aria® (golimumab)

Core Viewpoint - Alvotech and Teva Pharmaceuticals have announced that the FDA has accepted the Biologics License Applications for AVT05, a proposed biosimilar to Simponi and Simponi Aria, marking a significant step towards providing U.S. patients access to this biosimilar treatment for inflammatory conditions [1][2]. Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar space with a pipeline that includes nine disclosed candidates targeting various diseases [9]. - Teva Pharmaceuticals is a global pharmaceutical leader with a commitment to improving health outcomes through innovation and generics, employing approximately 37,000 people across 57 markets [10]. Strategic Partnership - Alvotech and Teva entered a strategic partnership in August 2020 for the exclusive commercialization of five biosimilar candidates, which has since expanded to nine products [3]. - Alvotech is responsible for development and manufacturing, while Teva handles commercialization in the U.S., leveraging its extensive sales and marketing infrastructure [3]. Regulatory Progress - The FDA review process for AVT05 is expected to be completed in the fourth quarter of 2025, with the applications being the first for a biosimilar candidate to golimumab [1]. - Alvotech has previously announced positive results from clinical studies comparing AVT05 to Simponi, indicating its efficacy and safety [2]. Market Developments - Two biosimilars developed under the Alvotech-Teva partnership have received FDA approval: SIMLANDI (adalimumab-ryvk) in February 2024 and SELARSDI (ustekinumab-aekn) in April 2024, with market entry planned for May 2024 and February 2025, respectively [4].