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news.Alvotech and global pharmaceutical company STADA Arzneimittel (STADA) announced that their Marketing Authorization Application for AVT04, the former’s proposed biosimilar to Stelara (ustekinumab), has been accepted by the European Medicines Agency (EMA).
The antibody is a biosimilar candidate to Stelara (ustekinumab). Credit: MasterTux from Pixabay.
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The two firms expect the agency to recommend marketing authorization approval for the monoclonal antibody AVT04, as soon as in the second half of this year.
Stelara is intended to treat various inflammatory conditions.
Ustekinumab attaches to IL-12 and IL-23 cytokines, which are involved in inflammatory and immune responses.
Alvotech chief scientific officer Joseph McClellan said: “We are pleased to be able to move closer to making AVT04 available to patients in Europe.
“Our goal is to meet an increasing need for broader access to affordable biologic medicines and Alvotech’s end-to-end biosimilars platform is designed to support the development and manufacture of multiple products simultaneously.”
The investigational product AVT04 has undergone confirmatory clinical, safety and efficacy study.
This study had met its primary endpoint in demonstrating therapeutic equivalence between the biosimilar candidate of Alvotech and the reference product in moderate to severe chronic plaque-type psoriasis patients.
The antibody is due to receive regulatory approval and its biosimilarity has not been established by regulatory authorities.
STADA specialty head Bryan Kim said: “The EMA’s acceptance for filing marks a key milestone in making an additional treatment option for inflammatory conditions available to patients and physicians in Europe.
“Authorisation for ustekinumab would add to STADA’s extensive range of six approved biosimilars in Europe, a portfolio that includes a high-concentration, citrate-free of adalimumab brought to market through our strategic partnership with Alvotech.”
