On 11 May 2026, Alvotech announced plans to resubmit Biologics License Applications for aflibercept (AVT06), denosumab (AVT03) and golimumab (AVT05) biosimilars in the US, following completion of an FDA “routine cGMP surveillance inspection” of the Alvotech Iceland manufacturing facility.
According to Alvotech, although the FDA issued Form 483 observations at the conclusion of its inspection, the observations “can be addressed quickly and do not raise any substantial issues with the site or its operations”. Alvotech expects to resubmit the BLAs in Q2/2026, and to secure approvals by the end of 2026.
Alvotech received Complete Response Letters from the FDA for its golimumab, aflibercept, and denosumab biosimilars BLAs in November 2025, December 2025 and January 2026, respectively, and subsequently undertook a “remediation project”.
Alvotech’s AVT05 (golimumab), biosimilar to Janssen’s Simponi®, was the first golimumab biosimilar to be approved worldwide, with its September 2025 approval in Japan. In the US, AVT05 will be commercialised by Teva, with the BLA for AVT05 initially accepted for review by the FDA in January 2025.
AVT06, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg) has a Q4/2026 US launch date (subject to FDA approval) under a settlement agreement with Regeneron/Bayer. AVT06 has already been launched in Germany (under the name Afiveg®) and in the UK, Canada and Japan (under the name Mynzepli®) and will be commercialised in the US by Teva.
Alvotech’s AVT03 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva®, is embroiled in BPCIA litigation commenced by Amgen in November 2025. Amgen’s complaint against Alvotech and its US commercialisation partner, Dr Reddy’s, alleges infringement of 31 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins like denosumab, and denosumab products.