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.

As Fierce Pharma points out, patent expirations are a routine occurrence in the pharmaceutical world, but 2025 stands out for ...

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

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 Food and Drug Administration has approved Fresenius Kabi's Biologics License Application for the denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht). These ...

The study explores whether Prolia/Xgeva (denosumab), a widely used therapy for osteoporosis and bone tumors, can regenerate ...

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

Celltrion gains Australian approval for three biosimilars in ophthalmology and bone disease Celltrion secures TGA endorsement ...