Alvotech (ALVO), a biotechnology company, on Thursday announced the re-submission of the Biologics License Applications (BLAs) for biosimilars ATV05 and ATV06 to the U.S. Food and Drug Administration (FDA).
AVT05 is a biosimilar to biologic medicines Simponi and Simponi Aria (golimumab), which are tumor necrosis factor (TNF) blockers used to treat a number of chronic inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis and polyarticular juvenile idiopathic arthritis.
AVT06 is a biosimilar to Eylea (aflibercept) 2 mg, a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of several retinal diseases that may lead to vision loss or blindness, including neovascular (wet) age-related macular degeneration, diabetic macular edema and retinal vein occlusion.
Both AVT05 and AVT06 were developed under a collaborative agreement between Alvotech and Teva Pharmaceutical Industries Ltd. (TEVA).
The re-submission follows the company's response to a post-application action letter (PAAL) from the FDA after the submission of the original BLA. The PAAL related to Alvotech's manufacturing facility in Reykjavik, and the company has since completed a good manufacturing practices (GMP) surveillance FDA inspection of the facility in May 2026.
The company expects the FDA to complete a six-month review of the applications, consistent with regulatory timelines.
ALVO closed Thursday at $32.83, down 0.76%. In the pre-market, shares are trading at $33, up 0.52%.
TEVA closed Thursday at $3.14, up 4.16%. In the pre-market, shares are trading at $3.08, down 1.91%.
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