Alvotech Resubmits BLAs for AVT05 and AVT06 with Six-Month FDA Review
ALVO•Alvotech resubmitted U.S. BLAs for AVT05 (golimumab) and AVT06 (aflibercept) after addressing FDA’s Post-Application Action Letter and cGMP inspection observations at its Reykjavik facility. The company expects a six-month FDA review and Teva will handle U.S. commercialization.
1. BLA Resubmission
Alvotech formally resubmitted Biologics License Applications to the U.S. Food and Drug Administration for AVT05, its proposed biosimilar to Simponi and Simponi Aria (golimumab), and AVT06, its proposed biosimilar to Eylea (aflibercept) 2 mg, following completion of responses to regulatory feedback.
2. Facility Inspection and Quality Enhancements
The company addressed observations from a routine cGMP surveillance inspection conducted in May 2026 at its Reykjavik manufacturing facility and fulfilled requirements outlined in the FDA’s Post-Application Action Letter, strengthening its quality systems and manufacturing operations under an ongoing enhancement program.
3. Regulatory Review and Commercial Partnership
Alvotech anticipates a standard six-month FDA review period for both applications and will leverage its partnership with Teva Pharmaceutical Industries for commercialization of AVT05 and AVT06 in the United States.
