On 27 January 2025, Alvotech and Teva Pharmaceuticals announced that the US FDA has accepted for review their Biologics Licence Applications for AVT05, biosimilar to Johnson & Johnson’s Simponi® and Simponi Aria® (golimumab), which are indicated for a variety of chronic inflammatory diseases. This is the first BLA filing acceptance for biosimilar golimumab in the US.
Alvotech/Advanz Pharma’s marketing authorisation application (MAA) for AVT05 was accepted by the European Medicines Agency in November 2024. This was the first golimumab biosimilar MAA to be filed and accepted anywhere in the world.
Alvotech expects the approvals process in both the EU and the US to be completed in Q4 2025.
AVT05 is being commercialised in the US by Teva pursuant to a strategic partnership entered into with Alvotech in August 2020. In May 2023, Alvotech and Advanz Pharma entered into a master licence and supply agreement to commercialise and supply AVT05 in Europe.