The FDA has approved two new denosumab biosimilars that are interchangeable with the reference medications Prolia and Xgeva, according to an industry press release.Denosumab-bnht (Conexxence/Bomyntra, ...

Denosumab-bnht is expected to launch in the US in June 2025 per an agreement with the reference product’s manufacturer, Amgen.

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

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

Denosumab works by specifically targeting the RANK ligand (RANKL), a critical protein in the lifecycle of osteoclasts, the ...

This month, Hanmi Pharmaceuticals and Samsung Bioepis entered into an agreement to develop and commercialize a denosumab biosimilar (SB16) referencing Amgen’s PROLIA ® in Korea. PROLIA ® is ...

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’ 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 ...

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

Telecommunications Consultants India (TCIL), a major stakeholder in Bharti Hexacom, has asked the company to begin a new ...

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