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 (ALVO) announced a long-term manufacturing agreement with LOTTE Biologics to expand its US manufacturing footprint and global supply network. LOTTE will manufacture drug substance for multiple antibody biosimilars, medicines developed to closely match existing biologic treatments, at its Syracuse, New York facility. The site has 40,000 liters of bioreactor capacity.
The additional capacity complements Alvotech’s existing partnerships and in-house capabilities. Alvotech expects its expanded manufacturing network to provide sufficient capacity for pipeline demand over the next ten years. Commercial supply remains subject to successful technology transfer, manufacturing qualification and applicable regulatory approvals. The collaboration could expand over time.
Alvotech (NASDAQ: ALVO) received FDA approval to manufacture SIMLANDI drug substance in a second production suite at its Reykjavik facility. SIMLANDI, also known as AVT02, is a biosimilar to Humira. The approval doubles manufacturing capacity available to support U.S. supply and allows commercial drug substance production in either DSM1 or DSM2.
The approval follows the FDA’s July 2026 closure of its latest Reykjavik inspection with a Voluntary Action Indicated classification. Alvotech expects the FDA to be able to act on other pending applications associated with the facility according to their respective goal dates. These cover AVT05, a proposed biosimilar to Simponi and Simponi Aria; AVT06, to Eylea; AVT03, to Prolia and Xgeva; and AVT16/AVT80, to Entyvio. Each application remains subject to individual FDA review and a regulatory decision.
Alvotech (NASDAQ: ALVO) announced that the U.S. FDA has accepted for review a Biologics License Application (BLA) for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab) in prefilled syringe and autoinjector formats for subcutaneous administration. Under Alvotech’s partnership with Teva, Alvotech leads development and manufacturing while Teva is responsible for commercialization.
The BLA is backed by analytical, pharmacokinetic and immunogenicity data, including a randomized, double-blind pivotal pharmacokinetic study in healthy adults that met all primary endpoints when comparing AVT80 to Entyvio. Regulatory advice supports using this study to demonstrate clinical similarity for both AVT80 and AVT16, Alvotech’s proposed interchangeable biosimilar to intravenous Entyvio, whose BLA was accepted by FDA in May 2026.
In the EU, the EMA has validated a Marketing Authorization Application covering both AVT16 (lyophilized vial) and AVT80 (pre-filled syringe and autoinjector). Alvotech notes that AVT16 and AVT80 remain investigational; biosimilarity and interchangeability have not yet been established or approved in any market.
Alvotech (NASDAQ: ALVO; ALVO-SDB) announced that Founder and Chairman Robert Wessman and Chief Strategy Officer Dr. Balaji V. Prasad will take part in two New York investor events in September 2026: a fireside chat at the Morgan Stanley 24th Annual Global Healthcare Conference on September 15 at 12:20 pm ET (16:20 GMT), and investor meetings at Deutsche Bank's 2026 Healthcare Summit on September 17.
A live webcast of the Morgan Stanley fireside chat will be available via the Investors section of Alvotech's website, with a replay accessible for 90 days.
Alvotech (NASDAQ: ALVO) announced a strategic licensing and commercialization agreement with Lotus Pharmaceutical for two biosimilar candidates: AVT34 (proposed biosimilar to Imfinzi, durvalumab) and AVT87 (proposed biosimilar to Hemlibra, emicizumab) in the U.S. and selected Asian markets.
Under a semi-exclusive U.S. arrangement, Alvotech may commercialize both products directly alongside Lotus, which will sell them through its subsidiary Alvogen. Alvotech will handle development, U.S. marketing authorizations, and serve as exclusive supplier globally. In Asia, Lotus receives exclusive commercialization rights in eight markets and will manage local regulatory filings. According to Alvotech, the deal has potential value of up to approximately $150 million in upfront and milestone payments, plus ongoing product supply revenues.
Alvotech (NASDAQ: ALVO) reported H1 2026 adjusted total revenue of $211.9 million, down from $306.1 million, with product and service revenue falling 48.3% to $105.9 million and license and other revenue rising 4.4% to $105.7 million. Adjusted EBITDA was $46.9 million versus $53.7 million and gross margin was 54%. Cash at June 30, 2026 was $142.8 million, compared with $172.4 million at year-end 2025.
Alvotech resubmitted U.S. BLAs for AVT05 and AVT06 and its partner resubmitted AVT03, with FDA decisions expected in Q4 2026, and FDA closed its Reykjavik plant inspection with a VAI classification. The company raised about $165 million through an equity offering and private placement and secured a new $75 million term loan. Management guides 2026 total revenue of $650–$700 million and adjusted EBITDA of $180–$220 million.
Alvotech (NASDAQ: ALVO; ALVO-SDB) will release its financial results for the first half of 2026 on Wednesday, August 19, 2026, after the U.S. market close.
The company will host a webcast with live Q&A on Thursday, August 20, 2026, at 08:00 ET (12:00 GMT, 13:00 BST, 14:00 CEST). Registration links are provided for both the webcast and Q&A, and presentation materials will be available on alvotech.com/financials before the call.
Alvotech (NASDAQ: ALVO; ALVO-SDB) announced that the U.S. FDA has closed its May 2026 inspection of the company’s manufacturing facility in Reykjavik, Iceland, and confirmed the site’s inspection classification as Voluntary Action Indicated (VAI).
According to Alvotech, the outcome reflects work to strengthen quality systems and manufacturing operations, and management believes actions taken have addressed the observations identified during the inspection. The company continues to work with the FDA to advance recent Biologics License Applications (BLAs) toward approval.
Alvotech recently resubmitted BLAs for AVT05 (biosimilar to Simponi) and AVT06 (biosimilar to Eylea), and the FDA accepted a BLA submission for AVT16 (proposed biosimilar to Entyvio) in June 2026. Alvotech reports five biosimilars already approved and marketed in multiple global markets and a pipeline of 13 disclosed biosimilar candidates across autoimmune, eye, bone, respiratory and oncology indications.
Alvotech (ALVO) disclosed manager-related transactions involving a significant share pledge. Filings with Luxembourg's CSSF report that Celtic Lux Holdings pledged 88,940,619 shares and 7,007,321 depository receipts in Alvotech. The transactions, classified as dealings by managers and closely associated persons, were dated June 26, 2026.
Alvotech (NASDAQ: ALVO) amended its credit agreement to add a $75 million term loan facility maturing December 31, 2027, led by GoldenTree Asset Management. The loan bears 12.50% interest, payable monthly in cash.
Alongside a recent $165 million equity raise and an existing $100 million term loan, Alvotech now has access to $240 million in new capital to fund its biosimilar R&D pipeline, FDA-related activities, product launches and global commercial expansion.