Alvotech (ALVO) said the FDA approved Process 2.0 for manufacturing SIMLANDI, its biosimilar to Humira, in the DSM2 manufacturing suite in Reykjavik, Iceland. The process more than doubles drug-substance output per batch without changing upstream manufacturing scale. Alvotech said it can produce the same quantity of drug substance in fewer batches, freeing capacity to support other products in its biosimilars portfolio.
Alvotech announced submission to the European Medicines Agency of an application for AVT29, its proposed biosimilar to Eylea® 8 mg. The application was submitted as a line extension to the existing European marketing authorization for Mynzepli® (AVT06), Alvotech’s biosimilar to Eylea® 2 mg. AVT29 remains investigational: it has not received regulatory approval, and biosimilarity has not yet been established by regulatory authorities.
Under the partnership, Alvotech is responsible for AVT06 and AVT29 development and commercial supply; Advanz Pharma is responsible for registration and commercialization in Europe. Advanz Pharma’s commercialization rights are exclusive in Europe except in Germany and France, where they are semi-exclusive. According to approved European product information, the 8 mg formulation allows treatment intervals of 16 weeks for certain patients, compared with the standard eight-week maintenance interval for the original 2 mg formulation, potentially reducing maintenance injection frequency. Based on publicly available information, this is the first worldwide regulatory submission for a proposed Eylea® 8 mg biosimilar.
Alvotech announced a long-term strategic manufacturing partnership with LOTTE Biologics. Under the agreement, LOTTE Biologics will manufacture drug substance for multiple antibody biosimilar products at its Syracuse, New York facility for global supply, with potential to expand the collaboration over time. The Syracuse site has 40,000 liters of bioreactor capacity and on-site process development and quality control capabilities. Alvotech said the agreement expands its U.S.-based manufacturing footprint. Alvotech CEO Lisa Graver said the company’s expanded global manufacturing network will have sufficient capacity to meet demand for its pipeline for the next ten years.
Alvotech said the FDA approved a supplement to the Biologics License Application for AVT02 (adalimumab-ryvk), marketed in the U.S. as SIMLANDI®, allowing drug substance for U.S. commercial supply to be made in either of the 2 production suites at its Reykjavik facility. Alvotech said adding DSM2 effectively doubles the drug-substance manufacturing capacity available to support U.S. supply.
DSM2 supports the full drug-substance process, including cell culture and purification, and was already approved for commercial drug substance for European markets. The approval follows the FDA’s July 2026 closure of its most recent Reykjavik inspection with a Voluntary Action Indicated (VAI) classification and further confirms resolution of inspection-related matters. Alvotech expects FDA action on other pending applications according to their respective goal dates; each remains subject to individual review and a regulatory decision.
Alvotech (ALVO) reports 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 use. Under its partnership with Teva, Alvotech leads development and manufacturing while Teva handles commercialization.
The BLA is supported by analytical, pharmacokinetic and immunogenicity data, including a randomized, double-blind, single-dose, three-arm pivotal study that met all primary endpoints. AVT80 complements AVT16, Alvotech’s proposed intravenous Entyvio biosimilar, for which the FDA accepted a BLA in May 2026, creating a two-presentation vedolizumab biosimilar program within Alvotech’s broader immunology pipeline. Both AVT16 and AVT80 remain investigational; no regulatory approvals have been granted and biosimilarity or interchangeability is not yet established.
Alvotech (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 United States and selected Asian markets.
Under a semi-exclusive U.S. arrangement, Alvotech will co-commercialize both products alongside Lotus, which will use its U.S. subsidiary Alvogen as commercial platform. Alvotech will handle development, U.S. marketing authorizations, and act as exclusive supplier globally. In eight Asian markets, Lotus receives exclusive commercialization rights and will manage local regulatory submissions.
The agreement has a potential value to Alvotech of up to approximately $150 million in upfront and milestone payments, plus ongoing product-supply revenues. The reference products Imfinzi and Hemlibra generated 2025 global sales of about $6.1 billion and CHF4.8 billion, respectively, highlighting the scale of the target markets.
Alvotech (ALVO) reported weaker results for the six months ended 30 June 2026. Total revenue was about $211.6 million, down from roughly $306.0 million, as product and service revenue fell 48% to $105.9 million amid ongoing manufacturing and quality-system enhancements at its Reykjavik facility.
License and other revenue held up better at $105.7 million, slightly above last year, driven by development and regulatory milestones across multiple biosimilar programs. The company swung to a net loss of $65.8 million from a $141.7 million profit, mainly due to sharply lower non‑cash gains on derivatives and higher finance costs of $81.8 million.
Alvotech raised $164.6 million in equity and secured an undrawn $75 million term loan facility, ending the period with $142.8 million in cash and a working capital surplus of $213.8 million. Adjusted EBITDA was $46.9 million, slightly below $53.6 million a year earlier. Management concluded there is no material uncertainty about the group’s ability to continue as a going concern.
Alvotech reports that the U.S. FDA has closed its May 2026 inspection of the company’s Reykjavik, Iceland, manufacturing facility and confirmed an inspection classification of Voluntary Action Indicated (VAI).
The company describes this as an important milestone reflecting work to strengthen quality systems and manufacturing operations and notes it continues working with the FDA to advance recent Biologics License Applications for AVT05, AVT06 and AVT16 toward approval. Alvotech states that five biosimilars are already approved and marketed in multiple global markets and that its current development pipeline includes 13 disclosed biosimilar candidates.
Alvotech has strengthened its liquidity by amending its existing credit agreement to add a new term loan facility of up to $75 million. The facility, led by funds managed by GoldenTree Asset Management and other existing lenders, carries a 12.50% interest rate payable monthly in cash and matures on December 31, 2027. This follows a recently announced $165 million equity capital raise, and together the equity financing and undrawn term loan facility give the company access to $240 million in new capital to support its biosimilar R&D pipeline, product launches and expansion of global commercial operations.
Celtic Holdings S.C.A. and Celtic Lux Holdings S.a r.l. updated their large shareholder disclosure for Alvotech. They report beneficial ownership of 107,450,988 Ordinary Shares, representing about 27.5% of Alvotech, based on 390,431,480 shares outstanding as of the company’s recent public offering and concurrent private placement.
On June 26, 2026, Celtic Lux bought 10,133,333 Ordinary Shares at $3.75 per share, investing $38,000,000 through a PIPE transaction funded by a $40,000,000 senior secured term loan. All Alvotech shares held by Celtic Lux, including the new PIPE shares, are pledged as collateral. Celtic Lux also entered into a 90‑day lock-up restricting sales and registration activity after the June 16, 2026 prospectus supplement, and received demand registration rights for the PIPE shares.