FDA Biosimilar Progress

Alvotech Resubmits FDA Applications for Simponi and Eylea Biosimilars After Facility Updates

Alvotech resubmitted to the U.S. Food and Drug Administration Biologics License Applications for AVT05, a proposed biosimilar to Simponi and Simponi Aria, and AVT06, a proposed biosimilar to Eylea 2 mg. The company says the filings follow its responses to an FDA Post-Application Action Letter tied to its Reykjavik, Iceland manufacturing facility and to observations from a routine cGMP surveillance inspection completed in May 2026, alongside continued strengthening of quality systems and manufacturing operations. Alvotech expects the FDA to conduct a six-month review of the resubmitted applications. Under its partnership with Teva Pharmaceutical, Alvotech handles development and manufacturing while Teva leads commercialization. Alvotech also frames the resubmission as a step toward moving past prior regulatory setbacks, including earlier pre-licensing inspection issues that led to a Complete Response Letter for AVT05 in late 2025.

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