Alvotech develops and manufactures biosimilar medicines for global markets. Company news centers on its approved and marketed biosimilars to Humira, Stelara, Simponi, Eylea and Prolia/Xgeva, along with disclosed candidates for autoimmune disorders, eye disorders, osteoporosis, respiratory disease and cancer.
Recurring updates cover financial results, annual reporting, FDA interactions tied to the Reykjavik manufacturing facility, biosimilar study results such as AVT80, supply and commercialization partnerships, intellectual-property settlements, executive changes and manufacturing-platform developments. Alvotech also reports on global commercial reach through partners across the United States, Europe, Japan, China and other international markets.
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Alvotech (NASDAQ: ALVO), a biotech firm specializing in biosimilars, has announced leadership changes in its Quality unit. Sandra Casaca is appointed as Chief Quality Officer, bringing over 25 years of global experience in pharmaceutical quality, having held positions at notable companies like BMS and Amgen. Sarah Tanksley will join Alvotech's Board of Directors, transitioning from her previous leadership role. Robert Wessman, CEO, expressed gratitude for Tanksley's contributions and welcomed Casaca, highlighting her extensive background in drug development and manufacturing operations. With eight biosimilar candidates targeting various diseases, Alvotech aims to expand its global footprint through strategic partnerships across multiple regions.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) has received a complete response letter (CRL) from the U.S. FDA regarding its partner Alvotech's (NASDAQ: ALVO) Biologics License Application for AVT02, a biosimilar to Humira (adalimumab). The FDA's CRL indicates that the application cannot be approved due to deficiencies identified at Alvotech's manufacturing facility, which need resolution. Despite this setback, Teva reaffirms its commitment to leadership in the biosimilars market and expresses optimism about its product pipeline, including further advancements with AVT02.
Alvotech (NASDAQ: ALVO) announced that the FDA issued a complete response letter (CRL) for its Biologics License Application (BLA) for AVT02, a biosimilar candidate for Humira. The CRL highlighted deficiencies that must be resolved following a recent FDA reinspection of Alvotech’s Reykjavik facility. No other application deficiencies were indicated. Alvotech submitted a comprehensive response to the FDA on April 3, 2023, and is awaiting further communication. Additionally, a second BLA for AVT02, aiming for potential interchangeability designation, is under review with a goal date of June 28, 2023. The company is focused on addressing the noted issues to ensure approval and aims to provide a high-concentration formulation of Humira for U.S. patients.
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Alvotech, a biotech company focused on biosimilars, announced the presentation of two posters at the 2023 American Academy of Dermatology Annual Meeting concerning its candidate AVT04 (ustekinumab), a proposed biosimilar to Stelara®. These posters detail pharmacokinetic and confirmatory clinical studies that support AVT04's biosimilarity and comparative outcomes. The Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency and a Biologics License Application (BLA) to the FDA earlier this year. The studies were conducted with healthy volunteers and patients, showing promising results.