공고 • Jul 01
Alvotech announced that it has received $175 million in funding On July 1, 2026, Alvotech closed the transaction. The company amended the terms of the transaction. The company received $175 million total gross proceeds in the transaction. The transaction included participation from funds managed by GoldenTree Asset Management LP and other existing lenders. The company received up to $75 million in its second and final tranche closing. 공고 • Jun 09
Alvotech Announces FDA Acceptance of Biologics License Application for AVT16, A Proposed Interchangeable Biosimilar to Entyvio Alvotech announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio (vedolizumab) lyophilized vial for intravenous administration. Under a partnership with Teva Pharmaceutical Industries Ltd., Alvotech is responsible for development and manufacturing of AVT16, while Teva is responsible for commercialization. FDA acceptance of the BLA for AVT16 is another important step in advancing access to biologic medicines for patients worldwide. Entyvio is a biologic medicine approved for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease. AVT16 is among Alvotech's disclosed biosimilar candidates in immunology and form part of the company's broader pipeline of biosimilar candidates aimed at expanding access to biologic medicines in major therapeutic areas. The BLA submission is supported by a comprehensive data package, including analytical, pharmacokinetic, and immunogenicity data generated to support the demonstration of biosimilarity between AVT16 and the reference product. AVT16 has been submitted as a proposed interchangeable biosimilar. In the United States, an interchangeable biosimilar may be substituted for the reference product at the pharmacy without the intervention of the prescriber, subject to applicable laws. If approved, AVT16 would add to the range of biosimilar options available to patients and healthcare providers in the United States. In February 2026, Alvotech announced positive results from a pivotal pharmacokinetic study for AVT80, a proposed biosimilar to Entyvio for subcutaneous administration. The randomized, double-blind, single-dose, parallel-group, three-arm study compared AVT80 to Entyvio in healthy adult participants and met all its primary endpoints. Based on regulatory advice, the clinical study is considered pivotal to support the demonstration of clinical similarity for both AVT16 and AVT80. AVT16 is a proposed interchangeable biosimilar candidate to Entyvio (vedolizumab), a humanized monoclonal antibody. AVT16 is being developed as a lyophilized vial for intravenous administration. In the European Union, the European Medicines Agency has validated a Marketing Authorization Application covering both AVT16 (lyophilized vial) and AVT80 (pre-filled syringe and auto-injector). AVT16 and AVT80 are investigational products and have not received regulatory approval in any markets. Biosimilarity and interchangeability have not been established by regulatory authorities and are not claimed. Entyvio (vedolizumab) is an integrin receptor antagonist indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease. Vedolizumab targets and binds specifically to the alpha-4-beta-7 integrin, which is involved in the migration of certain white blood cells into gastrointestinal tissue. 공고 • Jun 04
Alvotech Resubmits U.S. Biologics License Applications for AVT05 and AVT06 Alvotech announced the resubmission to the U.S. Food and Drug Administration (FDA) of Biologics License Applications (BLAs) for AVT05, a proposed biosimilar to Simponi and Simponi Aria (golimumab), and AVT06, a proposed biosimilar to Eylea (aflibercept) 2 mg. Under a partnership with Teva Pharmaceutical Industries Ltd., Alvotech is responsible for the development and manufacturing of AVT05 and AVT06, while Teva is responsible for commercialization. The resubmissions follow the submission of Alvotech’s response to the FDA’s Post-Application Action Letter (PAAL) related to the company’s Reykjavik manufacturing facility. In addition, the company has submitted responses to observations from a routine cGMP surveillance FDA inspection at the facility, completed in May 2026, and has continued to strengthen its quality systems and manufacturing operations as part of its ongoing enhancement program. The company expects the FDA to conduct a six-month review of the resubmitted applications, consistent with the applicable regulatory timelines. AVT05 is a proposed biosimilar to Simponi and Simponi Aria (golimumab), biologic medicines used to treat a variety of chronic inflammatory conditions. AVT06 is a proposed biosimilar to Eylea (aflibercept) 2 mg, a biologic medicine used to treat several serious retinal disorders, including conditions that may lead to vision loss or blindness. AVT05 is a biosimilar to Simponi (golimumab) that has been approved in multiple markets globally including in the European Economic Area (EEA), the United Kingdom, and Japan. In the United States, AVT05 is being developed as a biosimilar candidate to Simponi as a subcutaneous formulation and Simponi Aria as an intravenous formulation. AVT06 is a biosimilar to Eylea (aflibercept) 2 mg that has been approved in multiple markets globally, including in the European Economic Area (EEA), the United Kingdom, Japan and Canada. AVT03 is a biosimilar to Prolia and Xgeva (denosumab) that has been approved in multiple markets globally, including the EEA, the UK and Japan. Simponi (golimumab) is a subcutaneous tumor necrosis factor (TNF) blocker and Simponi Aria (golimumab) is the intravenous formulation. Simponi and Simponi Aria are approved for a range of chronic inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis and polyarticular juvenile idiopathic arthritis. Eylea (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of several retinal diseases including neovascular (wet) age-related macular degeneration, diabetic macular edema and retinal vein occlusion. Prolia /Xgeva (denosumab) is a monoclonal antibody used to treat osteoporosis and to prevent skeletal-related events in patients with certain cancers involving bone. 공고 • Mar 20
Alvotech Reaffirms Earnings Guidance for 2026 Alvotech reaffirmed earnings guidance for 2026. With continued focus on robust cash flow and margin expansion by delivering solid sales growth and driving operational efficiencies across the company, the company anticipates total revenues in the range of $650 million - $700 million in 2026, reflecting continued double-digit sales growth. 공고 • Feb 07
Alvotech Announces Positive Top-Line Results from Pivotal Pharmacokinetic Study for Proposed Biosimilar to Entyvio Alvotech announced positive top-line results from a pharmacokinetic (PK) study for AVT80, a biosimilar candidate to Entyvio (vedolizumab). The PK study (AVT80-GL-P01), which compared AVT80 to Entyvio in healthy adult participants, met all its primary endpoints. This was a randomized, double-blind, single dose, parallel-group design, 3-arm study, designed to demonstrate the PK similarity, and to investigate safety, tolerability, and immunogenicity profiles of AVT80 and Entyvio in healthy adults participants after administration of a single 108 mg/0.68 mL subcutaneous (SC) injection. Biosimiliarity has not been established by regulatory authorities and is not claimed. 
