Welcome to our dedicated page for Alvotech news (Ticker: ALVO), a resource for investors and traders seeking the latest updates and insights on Alvotech stock.
Alvotech (NASDAQ: ALVO) is a biotechnology company dedicated exclusively to biosimilars, and its news flow reflects the progress of a global biosimilar platform. Company updates frequently cover regulatory milestones, such as marketing authorizations in the European Economic Area, the United Kingdom and Japan for products referencing Prolia and Xgeva (denosumab), Simponi (golimumab) and Eylea (aflibercept). Press releases also highlight clinical and regulatory developments for new candidates, including submissions to agencies like the European Medicines Agency and the U.S. Food and Drug Administration.
Investors following ALVO news can expect regular announcements on product approvals, pipeline progress and legal or regulatory outcomes. Recent communications have described European Commission approval of AVT03, a biosimilar to Prolia and Xgeva, positive opinions from EMA committees for AVT03 and AVT05, and a settlement and license agreement enabling a future U.S. launch of AVT06, a proposed biosimilar to Eylea, subject to FDA approval. Other items include court decisions related to manufacturing activities for AVT06 and updates on applications for additional candidates such as AVT23.
Alvotech’s news flow also includes capital markets and financing transactions, such as senior unsecured convertible bond offerings and a senior term loan facility, which the company states are intended to support its research and development pipeline, manufacturing capacity and global product launches. Earnings-related press releases and business updates provide guidance ranges for revenues and adjusted EBITDA, along with commentary on order books, launch timing and investment programs.
Corporate governance and leadership changes are another recurring theme. For example, Alvotech has announced a planned CEO succession in which the founder will remain as Executive Chairman while a new Chief Executive Officer takes over day-to-day leadership. For users tracking ALVO, this news page offers a centralized view of regulatory, financial and strategic developments affecting the company’s biosimilar portfolio and global partnerships.
Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines development, has appointed Dr. Balaji V. Prasad as Chief Strategy Officer. Dr. Prasad brings 25 years of pharmaceutical industry experience, combining medical expertise with financial analysis background.
Most recently serving as a director and equities analyst at Barclays, Dr. Prasad covered US specialty pharma with Alvotech in his portfolio. His previous roles include portfolio manager at a Swiss asset management firm and leadership positions at Barclays and Goldman Sachs India healthcare coverage. He holds an MD from Bangalore Medical College and MBA from IIM Ahmedabad.
Alvotech (NASDAQ: ALVO) reported exceptional financial results for 2024, with total revenues reaching $492 million, a 427% increase year-over-year. Product revenues surged 462% to $273 million, while the company achieved positive Adjusted EBITDA of $108.3 million, compared to negative $291 million in 2023.
Key highlights include the successful submission and acceptance of three new proposed biosimilars in major global markets, the launch of SELARSDI™ (ustekinumab-aekn) in the U.S., and the acquisition of XBrane's R&D operations. The company reported an operating profit of $69.6 million, marking a significant improvement from the previous year's loss of $354.9 million.
Despite strong operational performance, Alvotech recorded a net loss of $231.9 million ($0.87 per share) for 2024, primarily due to finance costs and debt refinancing impacts. The company ended the year with $51.4 million in cash and cash equivalents.
Alvotech (NASDAQ: ALVO), along with Kashiv Biosciences and Advanz Pharma, announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted their marketing application for AVT23, a proposed biosimilar to Xolair® (omalizumab).
The biosimilar is intended for treating severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps. The original drug, Xolair, generated global sales of approximately $4.4 billion in 2024.
This development follows strategic partnerships formed in 2023, including a commercialization agreement between Alvotech and Advanz Pharma for AVT23 in February, an expanded partnership in May covering five additional biosimilar candidates, and a licensing agreement between Alvotech and Kashiv in October.
Alvotech (NASDAQ: ALVO) has announced the acquisition of Xbrane Biopharma AB's R&D operations and biosimilar candidate XB003 for approximately SEK 275 million (USD 27 million). The deal includes Xbrane's R&D facilities at Campus Solna, Karolinska Institute, Stockholm, establishing Alvotech's presence in the Swedish life science sector.
The purchase will be completed through SEK 102.2 million in cash and SEK 172.8 million in debt assumption, with creditors agreeing to accept SEK 152.8 million in Alvotech equity shares. The acquisition is expected to close in April 2025, pending regulatory and shareholder approvals.
This strategic move expands Alvotech's development capabilities and strengthens its position in the biosimilars market. The company currently operates with 19 commercial partners worldwide and has invested approximately $1.9 billion in its biosimilars platform since 2013. Xbrane will retain some pre-clinical development programs and continue as a listed company, maintaining over 75% of its portfolio's addressable market.
The FDA has accepted a Biologic License Application (BLA) for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab), jointly announced by Dr. Reddy's Laboratories and Alvotech. AVT03 aims to treat osteoporosis in post-menopausal women and prevent bone complications in cancer patients.
Under a License and Supply Agreement from May 2024, Alvotech will handle development and manufacturing, while Dr. Reddy's will manage registration and commercialization in applicable markets, including the U.S. Upon FDA approval, AVT03 will be available in two formulations: a 60 mg/1 mL single-dose prefilled syringe and a 120 mg/1.7 mL single-dose vial.
Alvotech (NASDAQ: ALVO) and Dr. Reddy's announced that the FDA has accepted their 351(k) Biologic License Application (BLA) for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab). The biosimilar aims to treat osteoporosis in post-menopausal women and prevent bone complications in cancer patients.
Under their License and Supply Agreement from May 2024, Alvotech will handle development and manufacturing, while Dr. Reddy's will manage registration and commercialization in key markets, including the U.S. Upon FDA approval, AVT03 will be available in two formulations: a 60 mg/1 mL single-dose prefilled syringe and a 120 mg/1.7 mL single-dose vial.
Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines development, has announced its participation in the Barclays 27th Annual Global Healthcare Conference in Miami, Florida from March 11-13, 2025.
The company's founder, chairman and CEO Robert Wessman, along with management team members, will conduct one-on-one meetings during the event. Additionally, Alvotech will participate in a fireside chat on March 12, 2025, from 9:30-9:55 am EDT. The session will be available via audio webcast in the Events Section of Alvotech's Investor Portal, with the recording accessible for 90 days post-event.
Alvotech and Teva Pharmaceuticals announced that the FDA has accepted for review Biologics License Applications (BLA) for AVT05, their proposed biosimilar to Simponi® and Simponi Aria® (golimumab). This marks the first U.S. BLA acceptance for a golimumab biosimilar candidate, with FDA review expected to complete in Q4 2025.
The announcement follows positive top-line results from clinical studies in April 2024 for rheumatoid arthritis patients and pharmacokinetic studies in November 2023. This development is part of a strategic partnership between Alvotech and Teva, which now encompasses nine biosimilar products.
The partnership has already achieved FDA approval for two other biosimilars: SIMLANDI® (adalimumab-ryvk) in February 2024 and SELARSDITM (ustekinumab-aekn) in April 2024. SIMLANDI launched in May 2024, while SELARSDITM is planned for U.S. market entry in February 2025.
Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines development, has scheduled its full year 2024 financial results announcement for March 26, 2025, after U.S. markets close. The company will host an analyst conference call on March 27, 2025, at 8:00 am ET (12 noon GMT).
A live audio webcast of the conference call will be available to investors, media, and the public. The webcast recording will remain accessible for 90 days after the event on Alvotech's investor website. Additionally, the company will host a local investor event in Icelandic at Sæmundargata 15-19, Reykjavik, on March 27, 2025, at 4:00 pm GMT.
Teva Pharmaceuticals and Alvotech have announced the U.S. availability of SELARSDI™ (ustekinumab-aekn), a biosimilar to Stelara®. The FDA approved SELARSDI in October 2024 for treating psoriatic arthritis, plaque psoriasis, Crohn's disease, and ulcerative colitis in adults and certain pediatric patients.
SELARSDI is the second biosimilar launched under the Teva-Alvotech partnership, which includes nine products. The FDA has provisionally determined SELARSDI's interchangeability with Stelara® following the expiration of exclusivity for the first interchangeable biosimilar on April 30, 2025.
The drug is available in four presentations: 45 mg/0.5 mL and 90 mg/mL in prefilled syringes, 45 mg/0.5 mL in single-dose vials for subcutaneous injection, and 130 mg/26 mL for intravenous infusion. Alvotech develops and manufactures the product, while Teva handles U.S. commercialization.