Alvotech (ALVO) announced that the U.S. FDA has completed a routine cGMP surveillance inspection of its Reykjavik, Iceland manufacturing site. The inspection concluded on May 8, 2026, with the FDA issuing a Form 483.
The company stated that the observations can be addressed quickly and do not raise substantial concerns about the facility's operations.
The outcome positions Alvotech to move forward with resubmissions of its Biologics License Applications for three biosimilars- AVT03 (denosumab), AVT05 (golimumab), and AVT06 (aflibercept). These BLAs had previously received Complete Response Letter (CRLs) in late 2025, citing deficiencies tied to the Reykjavik facility following a pre-license inspection in July 2025. The FDA did not identify any other issues with the applications.
Alvotech emphasized that improvements implemented since last year have strengthened the site's compliance fundamentals. The company continues to expect FDA approvals for the pending BLAs later in 2026.
The biosimilars under review target major therapeutic areas:
-AVT03 (denosumab)- biosimilar to Prolia/ Xgeva, for osteoporosis and bone-related conditions.
-AVT05 (golimumab)- biosimilar to Simponi, for autoimmune disorders such as rheumatoid arthritis and ulcerative colitis, developed in partnership with Teva Pharmaceuticals. -AVT06 (aflibercept)- biosimilar to Eylea, for eye disease including wet-age related macular degeneration, developed in partnership with Teva Pharmaceuticals.
Alvotech already markets biosimilars to Humira, and Stelara and has secured approvals for AVT03, AVT05 and AVT06 in Japan, the UK, and the European Economic Area. The company's U.S. progress remains contingent on resolving FDA facility concerns.
ALVO has traded between $3.03 and $11.85 over the past year. The stock closed Friday's trading (May 8, 2026) at $3.26, up 1.87%. In pre-market trading, the stock is at $3.32, up 1.84%.
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May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.