Teva receives FDA approval for biosimilar


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Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has reported that the FDA has accredited the biosimilar remedy it’s creating along with Alvotech. The FDA has dominated that SELARSDI, which the businesses have launched, is interchangeable with the biologic branded drug Stelara and can be utilized in all of the indications of the unique product.







Which means that the US well being system can exchange the branded drug with Teva and Alvotech’s biosimilar drug. The drug is designed to deal with grownup and pediatric psoriatic arthritis and plaque psoriasis, in addition to Crohn’s illness, and ulcerative colitis. The branded model is bought in massive portions by Johnson & Johnson, which markets the drug, and had reported gross sales of about $10.4 billion in 2024, down from $10.9 billion in 2023.

Teva SVP US biosimilars Thomas Rainey stated, “Teva’s latest launch of two biosimilars – SELARSDI and EPYSQLI – coupled with a wealthy pipeline of property anticipated to launch over the subsequent few years, place Teva to determine a powerful management place within the rising panorama of biosimilars and to drive development for the corporate because it embarks on the subsequent section of its technique.”

Teva’s share value has been rising not too long ago over constructive expectations on the Israeli pharmaceutical firm’s first quarter monetary outcomes, which shall be revealed on Wednesday. Teva, led by CEO Richard Francis, is presently buying and selling on Wall Road with a market cap of $18.6 billion.

Revealed by Globes, Israel enterprise information – en.globes.co.il – on Could 5, 2025.

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