Dr. Reddy’s and Alvotech shared that the Food and Drug Administration has accepted a 351(k) Biologic License Application submission for AVT03, which was developed by Alvotech, and is a proposed ...
REYKJAVIK, ICELAND (November 25, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today ...
On November 24, 2025, Alvotech announced that the European Commission (EC) has approved AVT03 as a biosimilar to Amgen’s PROLIA® and XGEVA® (denosumab) in the European Economic Area. AVT03 is approved ...
(RTTNews) - Alvotech (ALVO) announced that the European Commission has approved AVT03, a biosimilar to Amgen's Prolia and Xgeva for use across Europe. Prolia is indicated to treat osteoporosis and ...
REYKJAVIK, Iceland, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, ...
On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; 120 mg vial), referencing ...
Credit: Fresenius Kabi. Conexxence and Bomyntra were approved by the FDA in March 2025. The interchangeability designation allows the biosimilars to be substituted for the reference product at the ...
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