On 4 June 2026, Alvotech announced that it has resubmitted to the FDA its Biologics License Applications for AVT05 (golimumab), biosimilar to Janssen’s Simponi® and Simponi Aria®, and AVT06 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, 2mg. Alvotech expects the FDA to conduct a 6-month review of the resubmitted BLAs, in line with applicable regulatory timelines. Both AVT05 and AVT06 will be commercialised in the US by Teva.
The BLAs were resubmitted following completion of an FDA “routine cGMP surveillance inspection” of Alvotech’s Reykjavik manufacturing facility and the provision by Alvotech of responses to observations raised as a result of that inspection. Alvotech received Complete Response Letters from the FDA for its golimumab, aflibercept, and denosumab (AVT03) biosimilar BLAs in November 2025, December 2025 and January 2026, respectively, and subsequently undertook a “remediation project”.
Alvotech’s BLA for AVT05 was first accepted for review by the FDA in January 2025. In September 2025, AVT05 was the first golimumab biosimilar to be approved worldwide, with its approval in Japan as Gobivaz®. Gobivaz® received a positive CHMP opinion from the EMA in September 2025, followed by approval in Europe and the UK in November 2025, where it is commercialised by Advanz Pharma. Accord BioPharma’s Immgolis™ and Immgolis Intri™ were the first golimumab biosimilars approved in the US in May 2026, although their launch date is uncertain given ongoing BPCIA litigation commenced by Janssen against Accord/Bio-Thera in March 2026.
AVT06 (aflibercept, 2mg) has a Q4/2026 US launch date (subject to FDA approval) under a settlement agreement between Alvotech and Regeneron/Bayer. AVT06 has already been launched in Germany (under the name Afiveg®) and in the UK, Canada and Japan (under the name Mynzepli®). The only biosimilar aflibercept currently on the market in the US is Amgen’s Pavblu™, which launched in October 2024 after the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to the biosimilar. There are a number of approved aflibercept biosimilars, some of which have scheduled H2 2026 launch dates as a result of litigation settlements, including Biocon’s Yesafili® (approved May 2024, due to launch H2/2026), Formycon/Klinge’s Ahzantive® (approved June 2024, due to launch Q4/2026), Sandoz’s Enzeevu® (approved August 2024, due to launch Q4/2026), and Celltrion’s Eydenzelt® (approved October 2025, due to launch Q4/2026).
Dr Reddy’s, Alvotech’s partner in the US for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab), is responsible for resubmitting the BLA for that biosimilar. AVT03 is currently the subject of BPCIA litigation commenced by Amgen in November 2025 alleging infringement of 31 US patents.