Alvotech (ALVO), a biotechnology company, on Thursday said it has resubmitted Biologics License Applications (BLAs) to the U.S. Food and Drug Administration (FDA) for AVT05, a proposed biosimilar to Simponi and Simponi Aria, and AVT06, a proposed biosimilar to Eylea.
The resubmissions follow the company's responses to the FDA's Post-Application Action Letter related to Alvotech's manufacturing facility in Reykjavik, Iceland. The company also submitted responses to observations from a routine cGMP surveillance inspection completed in May 2026 and said it has continued to strengthen its quality systems and manufacturing operations as part of its ongoing enhancement program.
Alvotech expects the FDA to complete a six-month review of the resubmitted applications in line with applicable regulatory timelines.
Under a partnership with Teva Pharmaceutical Industries Ltd. (TEVA), Alvotech is responsible for the development and manufacturing of AVT05 and AVT06, while Teva handles commercialization.
Simponi, a subcutaneous formulation of golimumab, and Simponi Aria, an intravenous formulation, are used to treat chronic inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis, and are approved in multiple markets, including Europe, the United Kingdom and Japan.
Eylea is approved in multiple markets globally, including the European Economic Area (EEA), the United Kingdom, Japan and Canada, for the treatment of several retinal diseases, including neovascular (wet) age-related macular degeneration, diabetic macular edema and retinal vein occlusion.
Alvotech shares closed at $3.14 on Wednesday, up 4.67%.
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