The Icelandic biopharmaceutical firm Alvotech announced on Thursday that it has resubmitted Biologics License Applications to the US Food and Drug Administration for two biosimilar drugs, targeting Johnson & Johnson's Simponi and Regeneron's Eylea. This submission, advanced in partnership with Teva, represents a crucial step for both companies in expanding their presence within the US biosimilars market.
The two drugs are designated AVT05 and AVT06. AVT05 is a biosimilar for J&J's Simponi and its intravenous formulation Simponi Aria. This drug is a tumor necrosis factor blocker used to treat various chronic inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. AVT06 is a biosimilar for Regeneron's Eylea. Eylea is a vascular endothelial growth factor inhibitor used to treat retinal diseases that can lead to vision loss or blindness, such as neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion.
This resubmission follows a Complete Response Letter previously issued by the FDA regarding Alvotech's Reykjavik manufacturing facility. During a 2025 inspection, the FDA raised three primary observations concerning the use of silicone lubricant, complaint handling procedures, and microbial contamination. Alvotech has completed corrective actions and gathered approximately six months of data demonstrating sustainable improvement. The company completed an FDA Good Manufacturing Practice follow-up inspection of the facility in May 2026, and the FDA is expected to complete its review within six months according to the standard review timeline.
Previous clinical trial data indicated that AVT05 met the primary efficacy endpoint in a Phase 3 study involving patients with moderate to severe rheumatoid arthritis. The change in DAS28-CRP score at week 16 fell within the pre-specified equivalence margin, with safety and immunogenicity comparable to the reference product. AVT06 also demonstrated efficacy comparable to Eylea in a Phase 3 study for patients with neovascular age-related macular degeneration, with changes in best-corrected visual acuity within the pre-specified equivalence range and similar safety and pharmacokinetic profiles.
Alvotech's Chief Strategy Officer, Balaji Prasad, stated that Simponi represents the most time-sensitive opportunity in their product pipeline, with limited market competition, and the company aims to be among the first to market. For Eylea, the impact of timing is relatively less significant due to a relevant settlement agreement permitting a market launch in the fourth quarter. If these applications are approved smoothly, both products are anticipated to launch in the US market before the end of the year.