Alvotech (NASDAQ: ALVO) and STADA Arzneimittel (STADA) have received a favorable opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency regarding the marketing authorization application for Uzpruvo (AVT04). Developed by Alvotech, this biotech analogue of Stelara (ustekinumab) marks the first positive review for a Stelara biotech analogue in Europe. The CHMP's positive opinion will now be forwarded to the European Commission for a final decision on granting marketing authorization, applicable throughout the European Economic Area.

Under their partnership formed in 2019, Alvotech handles development and production, while STADA holds exclusive marketing rights for Europe. STADA currently markets five biotech analogues, including Hukyndra (AVT02), an analogue of Humira developed by Alvotech.

The announcement follows the CHMP's review, considering positive clinical trial results for AVT04 in patients with moderate and severe psoriasis, demonstrating comparable clinical activity to the reference drug Stelara.

STADA's Head of Specialty Medicines, expressed optimism about improving patient access to ustekinumab, emphasizing STADA's role in enhancing market competition with biotech analogues. The success of their partnership with Alvotech in commercializing a biotech analogue of Humira has positioned them well for expanding access to the Stelara analogue.

Alvotech, highlighted their joint efforts to increase access to the biotech analogue of Stelara for patients with inflammatory diseases. Ustekinumab, a human monoclonal antibody, is produced using the same cell line and production method as the reference drug Stelara. It interferes with cytokine pathways crucial to immune-mediated diseases like Crohn's disease, psoriasis, and psoriatic arthritis.

Stelara is utilized by approximately 95,000 patients in the four largest European Union countries and the United Kingdom. As one of Europe's top-selling drugs, the availability of biotech analogues offers a competitive alternative as the original drug's patent expires, contributing to enhanced patient access and reduced healthcare costs across European healthcare systems.

 

Source: globenewswire.com

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