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 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.
Alvotech (NASDAQ: ALVO) and Advanz Pharma announced on November 6, 2025 that the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisations for all four presentations of Gobivaz, a biosimilar to Simponi (golimumab).
The authorisations cover 50 mg/0.5 mL and 100 mg/mL formats in both pre-filled syringe and autoinjector forms for rheumatoid arthritis, psoriatic arthritis, axial spondylarthritis, ulcerative colitis (adults), and juvenile idiopathic arthritis across the United Kingdom. The EMA CHMP has issued a positive opinion recommending approval across the European Economic Area.
Under the partnership, Alvotech is responsible for development and commercial supply, while Advanz Pharma holds registration and exclusive commercialisation rights in Europe and the UK.
Alvotech (NASDAQ: ALVO) will release financial results for the first nine months ended September 30, 2025 after U.S. markets close on November 12, 2025. Management will host a conference call and webcast on November 13, 2025 at 8:00 AM EST (13:00 GMT, 14:00 CET) to present results and provide a business update, including the status of pending approvals in the U.S. and Europe.
Live audio and a Q&A participation line will be available, and an audio recording will be archived on the company investor portal for 90 days. Access details and the webcast link are posted at https://investors.alvotech.com/events/event-details/q3-2025-earnings.
Alvotech (NASDAQ: ALVO) will participate in the Morgan Stanley 23rd Annual Global Healthcare Conference in New York from September 8–10, 2025. The company will meet investors on September 9, 2025, and Dr. Balaji Prasad, Chief Strategy Officer, will take part in a fireside chat on September 10, 2025 at 10:45 am EDT (14:45 GMT / 16:45 CET). A live webcast of the fireside chat will be publicly available at the company investor events page.
A recording of the session will be available for replay for 90 days after the event.
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.