Core Viewpoint - The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted a marketing application for AVT23, a proposed biosimilar to Xolair, which is significant for increasing patient access to biologic treatments for severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps [1][2][4]. 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 biosimilar candidates targeting various diseases [7]. - Kashiv Biosciences is a fully integrated biopharmaceutical company dedicated to developing high-quality, cost-effective therapies, reflecting a commitment to innovation and global access to biosimilars [3]. - Advanz Pharma is a UK-based pharmaceutical company focused on specialty, hospital, and rare disease medications, emphasizing the expansion of treatment options for patients [4]. Product Information - AVT23 is an investigational biosimilar to Xolair (omalizumab), which targets free immunoglobulin E (IgE) and is indicated for severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps [5]. - Global sales of Xolair were approximately USD 4.4 billion in 2024, highlighting the market potential for AVT23 [1]. Strategic Partnerships - Alvotech and Advanz Pharma entered a commercialization agreement for AVT23 in February 2023, which was later expanded to include five additional biosimilar candidates [4]. - Alvotech and Kashiv announced a licensing agreement for AVT23 in October 2023, indicating a collaborative approach to bringing biosimilars to market [4].

REYKJAVIK, Iceland and STOCKHOLM, March 20, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the acquisition of Xbrane Biopharma AB's ("Xbrane") R&D operations and a biosimilar candidate (the "Acquisition"), further expanding Alvotech's development capabilities, and establishing a footprint in the Swedish life science sector. The Acquisition includes Xbrane's R&D operatio ...

Core Viewpoint - Alvotech has announced the acquisition of Xbrane Biopharma AB's R&D operations and a biosimilar candidate, XB003, which will enhance its development capabilities and establish a presence in the Swedish life science sector [1][3][6]. Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, with a significant investment of approximately $1.9 billion in R&D and manufacturing since 2013 [4][7]. - The company aims to be a leader in the biosimilar market by providing high-quality, cost-effective products and services, supported by a fully integrated approach and broad in-house capabilities [4][7]. Acquisition Details - The acquisition includes Xbrane's R&D operations located at the Karolinska Institute in Sweden and the biosimilar candidate XB003, which references Cimzia® (certolizumab pegol) [1][6]. - The purchase price for the acquisition is approximately SEK 275 million (around USD 27 million), consisting of SEK 102.2 million in cash and the assumption of SEK 172.8 million in debt and accounts payable [6]. - The closing of the acquisition is expected in April 2025, pending approvals from relevant authorities and Xbrane's shareholders [6]. Strategic Implications - This acquisition will allow Alvotech to expand its development capacity and enhance its commercial network, which includes 19 leading partners worldwide [3][4]. - Establishing a presence in Sweden's life science sector is expected to attract new talent and foster scientific collaboration, supporting Alvotech's growth strategy [3][6]. Xbrane's Position - Xbrane will retain over 75% of its addressable market, focusing on the commercialization of its remaining pre-clinical assets, including Ximluci (Lucentis biosimilar candidate) and Xdivane (Opdivo biosimilar candidate) [3][6].

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the acquisition of Xbrane Biopharma AB’s (“Xbrane”) R&D operations and a biosimilar candidate (the “Acquisition”), further expanding Alvotech’s development capabilities, and establishing a footprint in the Swedish life science sector. The Acquisition includes Xbrane’s R&D operations based in Campus Solna, at the Karolinska Institute outside Stockho ...

Core Insights - The FDA has accepted a Biologic License Application for AVT03, a proposed biosimilar of Prolia and Xgeva developed by Alvotech, in collaboration with Dr. Reddy's Laboratories [1][2][5] Company Overview - Dr. Reddy's Laboratories is a global pharmaceutical company based in Hyderabad, India, established in 1984, focusing on providing access to affordable and innovative medicines across various therapeutic areas [8] - Alvotech is a biotech company specializing in the development and manufacture of biosimilar medicines, aiming to be a global leader in the biosimilar space with a pipeline that includes nine disclosed biosimilar candidates [12] Product Details - AVT03 is a human monoclonal antibody and biosimilar candidate to denosumab, indicated for the treatment of osteoporosis and prevention of skeletal-related events in patients with advanced malignancies [6][4] - The product is expected to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 mL solution and a 120 mg/1.7 mL solution in a single-dose vial after FDA approval [5] Strategic Partnership - Dr. Reddy's and Alvotech entered into a License and Supply Agreement in May 2024, where Alvotech is responsible for the development and manufacturing of AVT03, while Dr. Reddy's handles registration and commercialization in applicable markets [5]

Core Insights - The FDA has accepted a Biologic License Application (BLA) for AVT03, a proposed biosimilar of Prolia® and Xgeva® developed by Alvotech, in collaboration with Dr. Reddy's Laboratories [1][2][5] Company Overview - Dr. Reddy's Laboratories is a global pharmaceutical company based in Hyderabad, India, established in 1984, focusing on providing access to affordable and innovative medicines across various therapeutic areas [8] - Alvotech is a biotech company specializing in the development and manufacture of biosimilar medicines, aiming to be a global leader in the biosimilar space with a pipeline that includes nine disclosed biosimilar candidates [12] Product Details - AVT03 is a human monoclonal antibody and biosimilar candidate to Prolia® and Xgeva®, which are both denosumab but in different presentations, targeting osteoporosis and skeletal-related events in patients with advanced malignancies [6][4] - The product is expected to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 mL solution and a 120 mg/1.7 mL (70 mg/mL) solution in a single-dose vial after FDA approval [5] Strategic Partnership - In May 2024, Dr. Reddy's and Alvotech entered into a License and Supply Agreement for AVT03, where Alvotech is responsible for development and manufacturing, while Dr. Reddy's handles registration and commercialization in applicable markets, including the U.S. [5]

Company Overview - Alvotech is a global biotech company focused on the development and manufacture of biosimilar medicines for patients worldwide [3] - The company aims to be a leader in the biosimilar space by delivering high-quality, cost-effective products and services through a fully integrated approach and broad in-house capabilities [3] - Alvotech has launched two biosimilars and has a development pipeline that includes nine disclosed biosimilar candidates targeting various diseases such as autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer [3] Strategic Partnerships - Alvotech has formed a network of strategic commercial partnerships to enhance its global reach and leverage local expertise in multiple markets, including the United States, Europe, Japan, China, and parts of South America, Africa, and the Middle East [3] - Notable commercial partners include Teva Pharmaceuticals, STADA Arzneimittel AG, Fuji Pharma Co., Ltd, and several others across various regions [3] Upcoming Events - Alvotech will participate in Barclays 27th Annual Global Healthcare Conference in Miami, Florida, from March 11-13, 2025, with CEO Robert Wessman and the management team hosting one-on-one meetings [1] - A fireside chat is scheduled for March 12, 2025, at 9:30-9:55 am EDT, which will be accessible via an audio webcast for investors and the general public [2]

Core Viewpoint - Alvotech is set to release its financial results for the full year 2024 on March 26, 2024, and will hold a conference call for analysts on March 27, 2025, indicating ongoing engagement with investors and analysts [1][2]. Company Overview - Alvotech is a biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a global leader in the biosimilar space by providing high-quality, cost-effective products [4]. - The company has two approved biosimilars, Humira® (adalimumab) and Stelara® (ustekinumab), which are marketed in multiple global markets [4]. - Alvotech's development pipeline includes nine disclosed biosimilar candidates targeting various conditions such as autoimmune disorders, eye disorders, osteoporosis, respiratory diseases, and cancer [4]. Strategic Partnerships - Alvotech has established a network of strategic commercial partnerships to enhance its global reach and leverage local expertise across various regions, including the United States, Europe, Japan, China, and parts of South America, Africa, and the Middle East [4]. - Notable commercial partners include Teva Pharmaceuticals, STADA Arzneimittel AG, Fuji Pharma Co., Ltd, and Dr. Reddy's, among others, each covering unique products and territories [4].

Core Insights - Teva Pharmaceutical Industries and partner Alvotech announced that the FDA has agreed to review their AVTO6 treatment for eye disorders, which is a biosimilar that could compete with Regeneron Pharmaceuticals' Eylea [1][3] - Eylea, which is used to treat conditions such as wet Age-related Macular Degeneration, had projected U.S. sales of $4.77 billion in 2024 [1] - Teva and Alvotech have been in a strategic partnership since August 2020, focusing on the U.S. biosimilar drug market and are developing a higher-dose version of the treatment to compete with Eylea HD [2][3] Market Reaction - Following the announcement, Teva's shares increased by approximately 3%, while Alvotech's shares decreased by 0.8% [2] - Regeneron Pharmaceuticals' shares rose by about 1.7% in response to the news [2]

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept), a biologic used to treat eye disorders, including diseases which ca ...