Alvotech

The FDA approved Imuldosa (ustekinumab-srlf), a biosimilar to Stelara, for treating autoimmune diseases. Stelara, a top-grossing biologic, generated $10.86 billion globally in 2023. Imuldosa is the fifth ustekinumab biosimilar approved in the US, developed by Dong-A ST and Meiji Seika Pharma, and will be commercialized by Intas Pharmaceuticals.

The FDA approved Imuldosa (ustekinumab-srlf), a biosimilar to Stelara, for treating plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis. Stelara, a top-grossing biologic, generated $10.86 billion globally in 2023. Imuldosa is the fifth ustekinumab biosimilar approved by the FDA, developed by Dong-A ST and Meiji Seika Pharma, and will be commercialized by Intas Pharmaceuticals.

Dong-A ST receives FDA approval for Imuldosa, a Stelara biosimilar, set to launch in the US amidst a crowded market. Stelara's sales are forecasted to decline post-2023 patent expiry, with biosimilars like Amgen's Wezlana and Samsung Bioepis's Pyzchiva expected to launch in 2025.

Arzneimittel AG announced EMA's review of AVT03, a biosimilar candidate to Prolia and Xgeva (denosumab), for osteoporosis and cancer-related bone complications. Alvotech develops and manufactures AVT03, while STADA will market it in Europe and selected regions. AVT03 studies met primary endpoints for efficacy, safety, and pharmacokinetics in osteoporosis and healthy participants. The European denosumab market is valued at €1 billion, with biosimilar competition potentially expanding patient access.

Alvotech announced EMA acceptance of a Marketing Authorization Application for AVT03, a biosimilar candidate to Prolia® and Xgeva® (denosumab). AVT03, developed by Alvotech, aims to provide affordable biologic medicines, with positive topline results from confirmatory patient studies demonstrating clinical similarity to Prolia in terms of efficacy, safety, immunogenicity, and pharmacokinetics. Alvotech has commercialization agreements with STADA Arzneimittel AG and Dr. Reddy’s Laboratories SA for AVT03 in Europe, including Switzerland and the UK.

Alvotech's AVT03, a biosimilar candidate to Amgen's Prolia and Xgeva (denosumab), has had its Marketing Authorization Application accepted by the EMA. AVT03 targets osteoporosis and bone complications in cancer patients. The European denosumab market is valued at $1 billion, with biosimilar competition potentially expanding patient access.

EMA accepts Marketing Authorization Applications for AVT03, a proposed denosumab biosimilar to Prolia® and Xgeva®, with STADA holding marketing rights in Europe and selected markets in Central Asia and the Middle East.

Alvotech announced EMA acceptance of its Marketing Authorization Application for AVT03, a biosimilar candidate to Prolia® and Xgeva® (denosumab). AVT03 aims to treat osteoporosis and prevent bone complications in cancer patients, potentially expanding patient access to affordable biologic medicines.