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Alvotech (NASDAQ: ALVO) is a global biopharmaceutical company specializing in the development and manufacturing of high-quality biosimilar medicines aimed at enhancing patient access to affordable treatments worldwide. Established in 2013, the company has committed itself to becoming a leader in biogenerics, focusing on the creation of cost-effective biosimilars that meet stringent quality standards. Alvotech operates through a fully integrated model, addressing every step from cell line development to commercial manufacturing.
Alvotech's headquarters in Reykjavik, Iceland hosts a state-of-the-art flexible manufacturing facility that underscores the company's commitment to high-quality and efficient production. The company's portfolio includes biosimilars for autoimmune disorders, eye conditions, osteoporosis, respiratory diseases, and cancer. Alvotech has successfully launched two biosimilars and is actively working on nine more candidates.
In recent developments, Alvotech announced positive top-line results for AVT05, a proposed biosimilar to Simponi® and Simponi Aria®, and has received FDA approval for AVT04, a biosimilar to Stelara®. The company is also advancing in its U.S. strategic partnership with Teva Pharmaceuticals for the high-concentration interchangeable biosimilar to Humira®, marketed under Quallent’s private label. Financially, Alvotech reported increased revenues of $37 million in Q1 2024 and strengthened its position with a strategic refinancing transaction led by GoldenTree Asset Management, enhancing its financial flexibility and reducing upcoming debt maturities.
Alvotech's global reach is bolstered by strategic commercial partnerships with renowned pharmaceutical companies like Teva, STADA Arzneimittel AG, Fuji Pharma Co., Ltd., and many others. These collaborations extend across the United States, Europe, Japan, China, and several other regions, leveraging local expertise to provide expansive market access.
For more information on Alvotech and to stay updated with the latest news, visit www.alvotech.com.
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.
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.
Alvotech reported a 114% increase in total revenue for the full year 2022, reaching $85.0 million compared to $39.7 million in 2021. The growth was driven by milestone and product revenue from the commercialization of AVT02, a biosimilar to Humira®, across 17 countries. The company advanced three biosimilar candidates into clinical development and submitted marketing applications for AVT04, a proposed biosimilar to Stelara®. Despite the revenue growth, Alvotech reported a net loss of $513.6 million. The FDA has set an action date of April 13, 2023, for AVT02's licensing application, and a reinspection of the Reykjavik manufacturing site is scheduled for March 6, 2023.
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