Alvotech develops and manufactures biosimilar medicines for global markets. Company news centers on its approved and marketed biosimilars to Humira, Stelara, Simponi, Eylea and Prolia/Xgeva, along with disclosed candidates for autoimmune disorders, eye disorders, osteoporosis, respiratory disease and cancer.
Recurring updates cover financial results, annual reporting, FDA interactions tied to the Reykjavik manufacturing facility, biosimilar study results such as AVT80, supply and commercialization partnerships, intellectual-property settlements, executive changes and manufacturing-platform developments. Alvotech also reports on global commercial reach through partners across the United States, Europe, Japan, China and other international markets.
Alvotech (NASDAQ: ALVO), in partnership with Kashiv Biosciences and Advanz Pharma, announced positive topline results from their confirmatory efficacy study for AVT23, a proposed biosimilar to Xolair® (omalizumab). The study met its primary endpoint, demonstrating therapeutic equivalence and comparable safety to Xolair® in patients with Chronic Spontaneous Urticaria (CSU).
The double-blind study enrolled 600 patients, with 400 receiving the confirmatory dose of 300mg. The primary efficacy measure focused on changes in weekly Itch Severity Score at Week 12. The UK MHRA has already validated the marketing authorization application, with an EMA filing expected by year-end.