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 is an Iceland-based biotechnology company specializing in biosimilars—cost-controlled alternatives to expensive biologic therapies. News coverage for Alvotech typically focuses on regulatory milestones, product approvals, and commercial developments as the company advances its biosimilar portfolio through global markets.
Investors following Alvotech news can expect updates on marketing approvals from regulatory agencies including the FDA, European Medicines Agency, and other international health authorities. Biosimilar approvals represent critical value inflection points, as each approval enables market entry for products that took years to develop. Clinical trial results and regulatory submissions also generate newsworthy developments, as these milestones indicate progress through the lengthy biosimilar development pathway.
Commercial partnerships and licensing agreements frequently appear in Alvotech's news flow. The company collaborates with established pharmaceutical partners for product commercialization in various markets, and announcements of new partnerships, territory expansions, or commercial launches provide insight into the company's market penetration strategy. Manufacturing expansions and capacity additions also generate coverage, reflecting the capital-intensive nature of biologic production and the company's ability to scale operations.
Financial developments including capital raises, debt financings, and quarterly results offer transparency into Alvotech's funding position and commercial progress. As a foreign private issuer based in Iceland with shares trading on NASDAQ, the company's financial disclosures and investor communications follow international reporting frameworks. Legal settlements and intellectual property developments may also appear in news coverage, as biosimilar companies navigate patent landscapes and potential litigation with reference product manufacturers.
This news resource provides comprehensive coverage of Alvotech's regulatory, commercial, and corporate developments, helping investors track the company's progress in the specialized biosimilars market. Bookmark this page to monitor important developments for this Iceland-based biotechnology company.
Alvotech (NASDAQ: ALVO) announced on November 24, 2025 that the European Commission approved AVT03 as a biosimilar to Prolia and Xgeva (denosumab) in the European Economic Area.
AVT03 is approved in two presentations: 60 mg/mL pre-filled syringe for osteoporosis (Prolia) and 70 mg/mL vial for prevention of skeletal related events in advanced malignancies (Xgeva). The European denosumab market is stated at approximately US$1.2 billion in the last 12 months through Q2 2025. Commercialisation in Europe will be via partnerships with STADA and Dr. Reddy’s under semi-exclusive rights.
Alvotech (NASDAQ: ALVO) and Advanz Pharma announced that the European Commission granted marketing authorizations across the EEA for Gobivaz® (golimumab biosimilar) on Nov 20, 2025.
The approvals cover 50 mg/0.5 mL and 100 mg/mL in pre-filled syringe and autoinjector formats for adult indications including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, ulcerative colitis, and for juvenile idiopathic arthritis in children aged 2 years and older.
The EC decision follows a positive CHMP opinion in September and relied on analytical and clinical data, including positive confirmatory study topline results announced in April 2024.
Alvotech (NASDAQ: ALVO) reported first nine months 2025 results: total revenues $420.0M (+24% YoY), product & service revenue $237.4M (+85% YoY) and adjusted EBITDA $68M (down 21% YoY). The company reiterated a revised full‑year outlook of $570–$600M revenue and $130–$150M adjusted EBITDA.
Operational highlights include multiple marketing approvals and positive CHMP opinions in Japan and Europe, a $42.8M cash balance at 30‑Sep‑2025, $1.1B total borrowings, a $100M new working capital facility, and appointment of Joseph McClellan as COO. An earnings call is scheduled for Nov 13, 2025.
Alvotech (NASDAQ: ALVO) said the European Medicines Agency CHMP issued a positive opinion recommending approval of AVT03, its proposed biosimilar to Prolia® (denosumab 60 mg/mL pre-filled syringe) and Xgeva® (denosumab 70 mg/mL vial), on September 22, 2024. The company said AVT03 remains under EMA review with a final European Commission decision pending. Upon approval, commercial partners STADA and Dr. Reddy’s will market the product in Europe under semi-exclusive rights with assigned tradenames Kefdensis, Zvogra, Acvybra and Xbonzy.
This step affects access to denosumab therapies indicated for osteoporosis, fracture risk and oncology bone complications and moves AVT03 closer to potential European commercialization pending the final regulatory decision.
Alvotech (NASDAQ: ALVO) will release financial results for the six months ended June 30, 2025, after U.S. markets close on Wednesday, August 13, 2025.
The company will host a conference call to present results and business highlights on Thursday, August 14, 2025 at 8:00 am EDT (12:00 noon GMT, 14:00 CET). Live audio will be webcast on Alvotech's investor portal and the webcast will be archived for replay for 90 days. Access details and phone sign-in instructions are posted at https://investors.alvotech.com/events/event-details/q2-2025-earnings.
Alvotech (NASDAQ: ALVO) won expedited UK High Court proceedings brought by Regeneron and Bayer, which rejected requests for an injunction blocking manufacturing at Alvotech’s UK CMO for its biosimilar AVT06 (aflibercept), a biosimilar to Eylea.
The decision permits Alvotech to continue manufacture and storage of AVT06 in the UK for distribution in the UK, EEA and other countries and supports commercial launches after the expiry of Eylea Supplementary Protection Certificates on November 23, 2025. AVT06 received European Commission approval on August 21, 2025 and MHRA approval on August 28, 2025.
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.
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