Alvotech, Teva Announce US FDA Approval Of SELARSDI, Biosimilar To Stelara
Portfolio Pulse from Benzinga Newsdesk
The FDA has approved SELARSDI, a biosimilar to Stelara, for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients 6 years and older. This approval comes under the strategic partnership between Teva and Alvotech, with Teva being responsible for the exclusive commercialization of SELARSDI in the United States.
April 16, 2024 | 9:33 pm
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POSITIVE IMPACT
Alvotech gains FDA approval for SELARSDI, a biosimilar to Stelara, marking a significant milestone in its portfolio.
FDA approval of SELARSDI significantly enhances Alvotech's product portfolio and positions the company strongly in the biosimilar market. This approval is likely to boost investor confidence in Alvotech's capabilities in developing and gaining approval for biosimilar products, potentially leading to a positive impact on its stock price in the short term.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 90
POSITIVE IMPACT
Teva secures exclusive rights to commercialize FDA-approved SELARSDI in the US, potentially boosting its market presence in biosimilars.
Teva's exclusive commercialization rights for SELARSDI in the US, following FDA approval, could significantly enhance its position in the biosimilar market and contribute to revenue growth. This strategic partnership with Alvotech and the addition of SELARSDI to its portfolio are likely to be viewed positively by investors, potentially leading to a short-term uplift in Teva's stock price.
CONFIDENCE 85
IMPORTANCE 85
RELEVANCE 80