Alvotech Form 6-K Summary (Nov 2025)

Alvotech reported receiving a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for AVT05, a biosimilar candidate for Simponi® (golimumab).

• Critical Event: FDA CRL issued November 2, 2025.
• Impact: The Company has consequently reevaluated its 2025 outlook.
• Filing Status: Exhibit 99.1 (Press Release) is furnished, detailing the adverse regulatory decision.

This filing signals an unexpected delay in the commercialization timeline for AVT05, requiring investors to monitor the