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Alvotech proposed biosimilar to Stelara accepted by EMA



The companies anticipate that the EMA could also recommend marketing authorisation for AVT04

Alvotech – a company which focuses on the development of biosimilar therapies – and STADA have announced that the European Medicines Agency (EMA) has accepted a marketing authorisation application for AVT04.

The treatment is a proposed biosimilar to Stelara – also known as ustekinumab. The companies anticipate that the EMA could also recommend marketing authorisation for AVT04 later this year.

In May last year, Alvotech announced that a clinical, safety and efficacy study for AVT04 had met its primary endpoint. During the study, therapeutic equivalence between Alvotech’s biosimilar candidate and the reference product, in patients with moderate-to-severe chronic plaque-type psoriasis, was duly established.

Meanwhile, in May 2022, Alvotech also revealed positive top-line results from a pharmacokinetic similarity study for AVT04.

STADA’s head of specialty, Bryan Kim, was optimistic about AVT04’s chances: “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.”

He added: “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.”

Joseph McClellan, chief scientific officer at Alvotech, concluded: “We are pleased to be able to progress 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.”

Back in November 2019, STADA and Alvotech announced a strategic collaboration to commercialise eight biosimilar candidates developed by Alvotech across Europe. The companies have already launched marketing and sales of their first biosimilar – high-concentration adalimumab – in 16 countries in Europe.

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