Biosimilars

A second trial shows Novo Nordisk’s Wegovy improves heart health. Meanwhile, many other drugs are beginning to face generic competition, including from newly approved biosimilars.
FDA
Amid one of the industry’s steepest patent cliffs, the regulator Thursday approved Sandoz’s Tyruko, the first biosimilar for treating relapsing multiple sclerosis in adults. Sandoz is a division of Novartis.
The consumer healthcare brand is joining the growing biosimilars market in the U.S. with its new subsidiary Cordavis, which will market a Humira biosimilar as its first product.
Following two BLA rejections for its Humira biosimilar, Alvotech is expanding its partnership with Teva Pharmaceuticals, which will enable the latter to have greater involvement with quality and control.
Industry advocates argue price negotiation via the IRA may jeopardize the prices relied upon by biosimilar manufacturers to recoup their investments.
AbbVie’s Humira will now face competition from new biosimilars, including Boehringer Ingelheim’s Cyltezo, Celltrion’s Yuflyma, Organon and Samsung’s Hadlima, and Sandoz’s Hyrimoz.
Biosimilars effectively lowered cancer therapy Herceptin prices and made trastuzumab more accessible to patients, finds a new study from the USC Schaeffer Center.
The company’s Humira biosimilar Yusimry will launch in July with a $995 list price. Mark Cuban’s online pharmacy will sell it at a list price of $569.27 plus fees.
While the exact settlement details are confidential, the deal will allow Amgen to launch its Stelara biosimilar no later than January 1, 2025.
AbbVie has officially reached the Humira cliff, and 2023 estimates are feeling the effects. The Illinois-based biopharma shared its Q4 and full-year 2022 results Thursday morning.
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