Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application for AVT05, Alvotech’s proposed biosimilar to Simponi® (golimumab). This is a significant step toward expanding treatment options for chronic inflammatory diseases in Europe. The EMA's decision marks what is believed to be the first global filing for a biosimilar candidate to Simponi.
Alvotech's Chief Scientific Officer, Joseph McClellan, stated, "This is a welcome milestone for us, our partners, patients, and caregivers, as we take one step closer to being able to offer access to biosimilar Simponi." He also noted that Alvotech's in-house capabilities, utilizing a host cell line and process similar to the reference biologic, provided a head start in developing the biosimilar candidate.
Clinical Data Supporting AVT05
In April 2024, Alvotech reported positive top-line results from a confirmatory clinical study. The study compared the efficacy, safety, and immunogenicity of AVT05 with Simponi® in patients with moderate to severe rheumatoid arthritis. Prior to this, in November 2023, Alvotech announced positive topline results from a pharmacokinetic study. This study assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® in healthy adult participants.
AVT16 and AVT23
Alvotech is also developing AVT16, a biosimilar candidate to Entyvio® (vedolizumab), and AVT23, a biosimilar candidate to Xolair® (omalizumab). These products are investigational and have not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
Strategic Partnership
Alvotech and Advanz Pharma initially announced a commercialization agreement for AVT23 in February 2023. The partnership expanded in May 2024 to include five additional biosimilar candidates, including AVT05 and AVT16, along with three undisclosed early-stage biosimilars.
About Simponi
Simponi (golimumab) is a biologic drug used to treat several chronic inflammatory diseases. The EMA’s acceptance of AVT05 brings the possibility of a more affordable biosimilar option closer to reality. The approvals process is anticipated to be completed in the fourth quarter of 2025.
