The FDA approved denosumab-bmwo for all indications of the reference drugs Prolia and Xgeva. According to a settlement between Amgen and Celltrion, the biosimilars can be launched as early as June 1.
The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, ...
The Food and Drug Administration has approved Fresenius Kabi's Biologics License Application for the denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht). These ...
Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the approval of AVT03, a proposed biosimilar of Amgen’s AMGN Prolia ...