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) announced European launches beginning December 22, 2025 for Gobivaz (golimumab, AVT05), its biosimilar to Simponi. Gobivaz is described as the first marketed biosimilar to Simponi worldwide and will be commercialized exclusively in Europe by partner Advanz Pharma. In the UK, adoption is supported by an NHS England tender award, providing a defined procurement framework. Availability across EEA countries will follow national pricing and reimbursement processes. Approval was supported by analytical, pre-clinical and clinical studies; Gobivaz is offered in the same presentations and dosages as the reference product and is manufactured at Alvotech’s facility in Iceland.
Alvotech (NASDAQ: ALVO) and Teva reached a settlement and license agreement with Regeneron allowing Alvotech’s proposed biosimilar AVT06 (aflibercept) to be marketed in the U.S. in Q4 2026, or earlier under certain circumstances, if approved by the FDA. AVT06 has received marketing approvals in the United Kingdom, Japan and the 30 countries of the European Economic Area. A January 2024 confirmatory clinical study met its primary endpoint, showing high similarity to Eylea® in neovascular AMD. The settlement and Teva partnership position Alvotech for a potential U.S. launch pending FDA approval.
Alvotech (NASDAQ: ALVO) has placed USD 108 million senior unsecured convertible bonds due 22 December 2030 in a significantly oversubscribed private offering.
The bonds carry a 6.875% coupon, are issued at par, convert from day 41, and have an initial conversion price of USD 5.9224 (25% premium over USD 4.7379). Net proceeds will fund R&D, scaling production and four global product launches through 2026; the company expects R&D spend of about USD 250 million in 2026.
Concurrent activity included a USD ~56 million placement of existing shares to hedge bond investors, a full stock-lending facility, and lock-ups of 3 and 12 months for new shares and equity-linked securities.
Alvotech (NASDAQ: ALVO) launched a USD 100 million senior unsecured convertible bond offering due 2030 to fund R&D, manufacturing scale-up, global product launches and liquidity. The company plans to invest ~USD 250 million in R&D in 2026 and targets launching 4 new products globally during 2026, with three global launches already taking place in December 2025.
Alvotech reaffirmed 2025 guidance: $570–$600M revenue and $130–$150M adjusted EBITDA, and provided 2026 guidance: $650–$700M revenue and $180–$220M adjusted EBITDA. The company disclosed a U.S. settlement with Regeneron for AVT06 and noted potential FDA CRLs that could affect timing.
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) 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.