During its Q4/2025 Earnings Call on 19 March 2026, Alvotech provided updates on its launch plans and regulatory applications for various biosimilars, including golimumab, aflibercept, vedolizumab and pembrolizumab.
Alvotech confirmed that Gobivaz® (AVT05) was launched in the EU in December 2025 as the first available biosimilar to J&J’s Simponi® (golimumab), following its November 2025 EU marketing authorisation. Gobivaz® is being commercialised by Advanz Pharma in the UK and Europe under a May 2023 licence and supply agreement with Alvotech. In Japan, Alvotech’s commercialisation partner, Fuji Pharma, is planning to launch Gobivaz® (approved in September 2025) in May 2026. An application for approval of AVT05 has also been filed in Canada, with a decision expected in H1 2026. To date, the application for AVT05 is the only known golimumab biosimilar application filed in Canada.
Alvotech indicated that it is aiming to file the first regulatory submission for its high dose aflibercept biosimilar, AVT29, sometime in 2026. AVT29, biosimilar to Regeneron/Bayer’s Eylea™ 8mg/Eylea HD®, will be commercialised by Advanz Pharma in the EU and by Teva in the US. Under settlement agreements with Regeneron/Bayer, Alvotech has a Q4/2026 US launch date for AVT06 (biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), 2mg), subject to FDA approval, and various 2026 launch dates, with its partners STADA and Advanz Pharma having already launched AVT06 in Germany (under the name Afiveg®) and in the UK, Canada and Japan (under the name Mynzepli®), respectively.
Following the recent announcement of positive results from its PK study for AVT80, biosimilar to Takeda’s Entyvio® (vedolizumab), Alvotech said that it is planning to file regulatory submissions for a vedolizumab biosimilar later in 2026. Alvotech expects to be among the first to launch an Entyvio® biosimilar and has both IV (AVT16) and SC (AVT80) formulations in development.
As previously reported, Alvotech has a biosimilar to MSD’s Keytruda® (pembrolizumab) in its pipeline, on which it is partnering with Dr Reddy’s. During the Q4 2025 Earnings Call, Alvotech said that it is expecting it will be in a position to file a marketing authorisation application for the pembrolizumab biosimilar in 2028.
Alvotech also provided an update on the Complete Response Letters it received from the FDA in relation to its denosumab, golimumab and aflibercept biosimilars, announcing that it has undertaken a remediation project and is on track to resubmit its applications to the FDA in the first half of 2026.