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Teva receives FDA approval for biosimilar

by FeeOnlyNews.com
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Teva receives FDA approval for biosimilar
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Updated 18.42

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has reported that the FDA has approved the biosimilar treatment it is developing together with Alvotech. The FDA has ruled that SELARSDI, which the companies have launched, is interchangeable with the biologic branded drug Stelara and can be used in all the indications of the original product.





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This means that the US health system can replace the branded drug with Teva and Alvotech’s biosimilar drug. The drug is designed to treat adult and pediatric psoriatic arthritis and plaque psoriasis, as well as Crohn’s disease, and ulcerative colitis. The branded version is sold in large quantities by Johnson & Johnson, which markets the drug, and had reported sales of about $10.4 billion in 2024, down from $10.9 billion in 2023.

Teva SVP US biosimilars Thomas Rainey said, “Teva’s recent launch of two biosimilars – SELARSDI and EPYSQLI – coupled with a rich pipeline of assets expected to launch over the next few years, position Teva to establish a strong leadership position in the growing landscape of biosimilars and to drive growth for the company as it embarks on the next phase of its strategy.”

Teva’s share price has been rising recently over positive expectations on the Israeli pharmaceutical company’s first quarter financial results, which will be published on Wednesday. Teva, led by CEO Richard Francis, is currently trading on Wall Street with a market cap of $18.6 billion.

Published by Globes, Israel business news – en.globes.co.il – on May 5, 2025.

© Copyright of Globes Publisher Itonut (1983) Ltd., 2025.




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