On 4 November 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted their marketing authorisation application (MAA) for AVT05, biosimilar to Janssen’s Simponi® (golimumab), for treatment of several chronic inflammatory diseases. This is thought to be the first golimumab biosimilar MAA to be filed and accepted anywhere in the world. Alvotech/Advanz expect the approvals process to be completed in Q4 2025.
In April 2024, Alvotech was the first company to publicly announce positive topline results from a patient study evaluating a biosimilar candidate to Simponi® or Simponi Aria®. In November 2023, Alvotech announced that its pharmacokinetic study for AVT05 met its primary endpoint.
Alvotech and Advanz Pharma entered into a master license and supply agreement in May 2023 to commercialise and supply AVT05 in Europe. The agreement also included AVT16 (biosimilar to Takeda’s Entyvio® (vedolizumab) and three early stage, undisclosed biosimilar candidates.