Alvotech (ALVO), a biotechnology firm, announced on Thursday that it has resubmitted Biologics License Applications (BLAs) for its biosimilars AVT05 and AVT06 to the U.S. Food and Drug Administration (FDA).
AVT05 serves as a biosimilar to the biologic drugs Simponi and Simponi Aria (golimumab), which are tumor necrosis factor (TNF) inhibitors indicated for various chronic inflammatory conditions such as 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 used to treat several retinal disorders that can cause vision loss or blindness, including neovascular (wet) age‑related macular degeneration, diabetic macular edema, and retinal vein occlusion.
Both AVT05 and AVT06 were developed through a collaborative agreement between Alvotech and Teva Pharmaceutical Industries Ltd. (TEVA).
The resubmission follows the company’s response to a post‑application action letter (PAAL) issued by the FDA after the initial BLA submission. The PAAL pertained to Alvotech’s manufacturing site in Reykjavik, and the company has now completed a Good Manufacturing Practices (GMP) surveillance inspection by the FDA in May 2026.
The company anticipates that the FDA will complete a six‑month review of the applications, in line with standard regulatory timelines.
Alvotech (ALVO) closed on Thursday at $32.83, declining 0.76%, with pre-market trading at $33, up 0.52%.
Teva (TEVA) closed on Thursday at $3.14, rising 4.16%, while pre-market trading stood at $3.08, down 1.91%.