Milestone approval for first Stelara biosimilar in Europe
Authorities in Europe have granted marketing authorization for Uzpruvo (ustekinumab), a biosimilar of Johnson & Johnson’s (NYSE: JNJ) Stelara.
Developed by Germany’s STADA Arzneimittel (SAZ: Xetra) and Iceland-based Alvotech (Nasdaq: ALVO), the nod makes the companies the first to secure approval for a Stelara biosimilar in Europe.
It also represents a positive turnaround in fortunes, after the US Food and Drug Administration refused approval late last year, due to certain deficiencies noted during an inspection of Alvotech’s Reykjavik facility.
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