On 2 November 2025, Alvotech announced that the FDA has issued a complete response letter (CRL) for Alvotech’s Biologics Licence Application (BLA) for AVT05, biosimilar to J&J’s Simponi® (golimumab) in pre-filled syringe and autoinjector presentations. The CRL follows a pre-licence inspection of Alvotech’s Reykjavik manufacturing facility in July 2025 which identified “certain deficiencies” to be resolved. The CRL did not identify any other deficiencies with the BLA.
Alvotech’s Chairman and CEO, Robert Wessman, said that Alvotech is “disappointed in receiving the CRL” but expects “to resolve any outstanding issues and will continue to work with the FDA to bring this first to market biosimilar to patients in the US”.
AVT05 is being commercialised in the US by Teva pursuant to a strategic partnership entered into with Alvotech in August 2020. Alvotech/Teva’s Biologics Licence Application (BLA) for AVT05 was accepted by the FDA in January 2025.
AVT05 was the first golimumab biosimilar to be approved worldwide, with its September 2025 approval in Japan, where it is being commercialised by Fuji Pharma. It was also the subject of the first golimumab biosimilar MAA to be accepted anywhere in the world, when the European MAA for AVT05/Gobivaz® was accepted in November 2024. Gobivaz® received a positive CHMP opinion in Europe in September 2025.