2 November 2025 - Alvotech announced today that the US FDA has issued a complete response letter for Alvotech’s biologics license application for AVT05, in a pre-filled syringe and auto-injector presentations, a biosimilar candidate to Simponi (golimumab).

The complet response letter noted that certain deficiencies, which were conveyed following the FDA’s pre-license inspection of Alvotech’s Reykjavik manufacturing facility that concluded in July 2025, must be satisfactorily resolved before this BLA for AVT05 can be approved.

Read Alvotech press release