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) said the FDA issued a complete response letter (CRL) for its Biologics License Application for AVT05 (prefilled syringe and autoinjector), citing deficiencies from the FDA pre-license inspection of Alvotech’s Reykjavik facility completed in July 2025 that must be resolved before approval. The FDA identified no other application deficiencies and the facility remains FDA approved to manufacture and continues supplying commercial products. Sales of Simponi in the U.S. were less than $300 million in H1 2025 (IQVIA); no biosimilar to Simponi is currently approved in the U.S.
Alvotech lowered its 2025 outlook to $570–$600M revenue and $130–$150M adjusted EBITDA, citing investments and a temporary production slowdown to address the facility issues.
Alvotech (NASDAQ: ALVO) announced leadership changes in its global business development and commercial operations on October 21, 2025. Anil Okay, Chief Commercial Officer, is stepping down to become CEO of Adalvo. Trisha Durant joins as Senior Vice President, Global Business Development and Commercial Operation, ex-North America; Harshika Sarbajna is Senior Vice President Commercial, North America; and Agne Pasko becomes Vice President Head of Business Development.
The hires combine internal continuity and external experience across North America, Europe and global business development to support Alvotech’s commercial expansion.
Kashiv Biosciences (NASDAQ:ALVO) submitted a BLA to the U.S. FDA and had its MAA accepted by the EMA for ADL-018, a proposed biosimilar to XOLAIR® (omalizumab).
The company highlights ADL-018’s potential to be among the first-wave omalizumab biosimilars addressing a large market: ~$5.5B global, ~$4.1B U.S., and ~$1.0B E.U. annual sales (IQVIA, 12 months ending June 2025). Kashiv partners with Alvotech (AVT23) and cites Amneal’s commercial expectations for multiple biosimilar launches from 2026–2027.
Alvotech (NASDAQ: ALVO) and Advanz Pharma announced the EMA accepted a Marketing Authorization Application (MAA) for AVT23, a proposed biosimilar to Xolair (omalizumab), on Oct 6, 2025, the PR states.
The PR notes Alvotech developed AVT23 with Kashiv BioSciences and that Advanz Pharma holds licensed commercial rights in the EEA, UK, Switzerland, Canada, Australia, and New Zealand. The PR also states the UK MHRA accepted an MAA earlier in 2025. The companies frame the acceptance as a regulatory milestone toward broader patient access to omalizumab biosimilar therapy in respiratory and allergic indications.
Alvotech (NASDAQ: ALVO) has received a positive recommendation from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for AVT03, its proposed biosimilar to Prolia® and Xgeva® (denosumab).
Upon approval, the biosimilar will be marketed by STADA Arzneimittel AG and Dr. Reddy's Laboratories SA with semi-exclusive commercial rights in Europe, including Switzerland and the UK. The biosimilar will be available in two formulations: a 60 mg/mL pre-filled syringe and a 70 mg/mL vial, targeting conditions including osteoporosis in postmenopausal women, bone loss in cancer patients, and giant cell tumor of bone.
Alvotech (NASDAQ: ALVO) and Advanz Pharma have announced that the European Medicines Agency's CHMP has recommended marketing approval for Gobivaz®, a proposed biosimilar to Simponi® (golimumab). The biosimilar is intended for treating several chronic inflammatory diseases.
The recommendation covers 50 mg/0.5mL and 100mg/mL dosages in pre-filled syringe and autoinjector forms. The treatment is indicated for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis in adults and juvenile idiopathic arthritis across the EU, Norway, Iceland, and Lichtenstein.
The recommendation follows successful clinical trials, including positive top-line results from a confirmatory study in April 2024 and a pharmacokinetic study in November 2023.
Alvotech (NASDAQ: ALVO) has secured marketing approval from the Japanese Ministry of Health, Labor and Welfare for three new biosimilars through its partner Fuji Pharma. The approved products include: AVT03 (biosimilar to Ranmark®/denosumab), AVT05 (first-to-market biosimilar to Simponi®/golimumab), and AVT06 (biosimilar to Eylea®/aflibercept).
These approvals follow Alvotech's successful launch of its Stelara® biosimilar in Japan last year. The company's partnership with Fuji Pharma, established in 2018, includes rights to two additional biosimilar candidates under development, bringing their total collaboration to six products.
Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines development, will participate in the Morgan Stanley 23rd Annual Global Healthcare Conference in New York from September 8-10, 2025.
The company will conduct investor meetings on September 9, followed by a fireside chat featuring Dr. Balaji Prasad, Chief Strategy Officer, on September 10 at 10:45 am EDT. The fireside chat will be publicly accessible via webcast on Alvotech's investor relations website, with a 90-day replay period available after the event.
Alvotech (NASDAQ: ALVO) and Advanz Pharma have entered into a supply and commercialization agreement for AVT10, Alvotech's biosimilar candidate to Cimzia® (certolizumab pegol). The partnership targets the European market, with AVT10 being the only Cimzia® biosimilar under global development.
Cimzia®, a TNF-alpha inhibitor for inflammatory diseases, generated worldwide sales of US$2.3 billion in 2024. The companies plan to launch their first biosimilars in Europe in Q4 2025. This agreement adds to their existing partnership covering biosimilar candidates for more than ten reference biologics.
Alvotech (NASDAQ: ALVO) and Advanz Pharma have received European Commission approval for Mynzepli®, a biosimilar to Eylea® (aflibercept), for treating various retinal diseases. The approval covers all European Economic Area countries and follows positive clinical trial results demonstrating therapeutic equivalence to Eylea®.
The biosimilar is approved for treating multiple eye conditions including wet age-related macular degeneration (AMD), macular edema, diabetic macular edema (DME), and myopic choroidal neovascularization. Notably, Eylea® generated global sales of approximately $9 billion in 2024, with one-third from Europe.
Mynzepli® will be available as a 40 mg/mL solution for injection in both pre-filled syringe and vial formats. The approval is currently under review in other major markets, including the United States and Japan.