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  • 09/02/2023
  • Press Release

EMA Confirms Acceptance of Application for AVT04, a Proposed Biosimilar to Stelara® (ustekinumab)

  • Partners Alvotech and STADA have marketing authorization application (MAA) for ustekinumab accepted for filing by the European Medicines Agency (EMA)
  • EMA opinion on AVT04 could come as soon as the second half of 2023
  • Reference brand Stelara® (ustekinumab) is prescribed to treat a variety of inflammatory conditions

Reykjavik, Iceland & Bad Vilbel, Germany –
9 February 2023 – Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and global pharmaceutical company STADA Arzneimittel (STADA) today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab). The companies anticipate that the EMA could give recommend approving a marketing authorization for AVT04 as soon as in the second half of 2023.

“We are pleased to be able to progress closer to making AVT04 available to patients in Europe," said Joseph McClellan, Chief Scientific Officer of Alvotech. "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 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,” commented STADA’s Head of Specialty, Bryan Kim. “Authorization 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.”

In November 2019, Alvotech and STADA announced a strategic partnership to commercialize eight biosimilar candidates developed by Alvotech in Europe. As of December 2022, the companies had launched marketing and sales of the first biosimilar in the partnership, high-concentration adalimumab, in 16 countries in Europe.

In May 2022, Alvotech announced that a confirmatory clinical, safety and efficacy study for AVT04 had met its primary endpoint, in demonstrating therapeutic equivalence between Alvotech’s biosimilar candidate and the reference product in patients with moderate to severe chronic plaque-type psoriasis.  Earlier in May 2022, Alvotech also announced positive top-line results from a pharmacokinetic (PK) similarity study for AVT04.

* Stelara® is a registered trademark of Johnson & Johnson