Sandoz sues Amgen in U.S. court over Enbrel patents, alleging efforts to block biosimilar Erelzi and delay competition in the ...

Denosumab-bnht was approved as medication referencing Amgen’s Prolia and Xgeva. A settlement between Amgen and Fresenius Kabi will permit the biosimilar to launch in mid-2025 in the U.S ...

The biosimilar will launch in the United States in June 2025 as part of a global settlement with Amgen, which manufactures the reference product. The higher dosage of denosumab-bnht (Bomyntra ...

On March 26, 2025, the FDA approved Fresenius Kabi’s denosumab biosimilars, CONEXXENCE® (denosumab-bnht) and BOMYNTRA® (denosumab-bnht), referencing Amgen’s PROLIA® and XGEVA®, respectively.

Biosimilar denosumab of Alkem (Denuril) showed comparable efficacy, safety, pharmacokinetics, pharmacodynamics, and ...

The US Food and Drug Administration (FDA) has designated Celltrion’s Yuflyma (adalimumab-aaty) as an interchangeable biosimilar to AbbVie’s Humira (adalimumab). The decision allows Yuflyma to be ...

Accord received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for ...

Fresenius’ operating company Fresenius Kabi reached a global settlement with Amgen concerning their denosumab biosimilars, allowing launch in the U.S. in mid-2025 and in Europe later in H2 of ...

The study explores whether Prolia/Xgeva (denosumab), a widely used therapy for osteoporosis and bone tumors, can regenerate beta cells in patients with early type 1 diabetes.

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 ...

Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence ® (denosumab-bnht) and Bomyntra ® (denosumab-bnht) of its operating company Fresenius ...