STADA And Alvotech Receive Positive CHMP Opinion For Europe's First Ustekinumab Biosimilar To Stelara
Portfolio Pulse from Benzinga Newsdesk
STADA and Alvotech have received a positive CHMP opinion for Europe's first biosimilar to Stelara, Uzpruvo (AVT04), for use in gastroenterology, dermatology, and rheumatology. This marks the first EMA proposal for a biosimilar to Stelara, with potential market entry into the €2.5 billion EU ustekinumab market. STADA holds commercial rights in Europe, while Alvotech is responsible for development and manufacturing. The biosimilar could significantly expand patient access and provide cost-effective treatment options in the EU.
November 10, 2023 | 2:30 pm
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Alvotech, under the ticker ALVO, is set to benefit from the positive CHMP opinion for Uzpruvo, a biosimilar to Stelara, which could lead to increased market access and sales in the EU. This development is likely to be viewed positively by investors.
The positive opinion from CHMP is a crucial regulatory step that often precedes market approval. For Alvotech, this represents a significant milestone in expanding its biosimilar portfolio in the EU. Given the size of the ustekinumab market and the potential for cost savings with biosimilars, this news is likely to be seen as a strong positive by investors, potentially leading to an increase in Alvotech's stock price in the short term.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 90