Alvotech (NASDAQ:ALVO) and accomplice Stada Arzneimittel have acquired European advertising and marketing authorization for his or her biosimilar model of Johnson & Johnson’s (NYSE:JNJ) Stelara (ustekinumab), which is used to deal with sure inflammatory circumstances.
The European Fee cleared Uzpruvo (AVT04), Europe’s first ustekinumab biosimilar, on the market in all European Financial Space nations, together with the 27 EU member states in addition to in Iceland, Liechtenstein, and Norway.
The approval got here after the Committee for Medicinal Merchandise for Human Use inside the European Medicines Company adopted a constructive opinion on approving Uzpruvo with the indications Crohn’s illness, psoriasis and psoriatic arthritis.
Alvotech (ALVO) is liable for creating and manufacturing the AVT04 ustekinumab biosimilar as a part of a strategic partnership that started in 2019. Stada holds industrial rights inside Europe, the place the corporate already markets six authorised biosimilars, together with in gastrointestinal, dermatology and rheumatology indications.
The authorization paves method for biosimilar competitors within the roughly €2.5B EU ustekinumab market with the Stelara IP rights expiring in July 2024.
