From Crohn disease to uncomplicated urinary tract infections and beyond, the FDA issued several high-impact drug approvals last month.

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 ...

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 ...

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

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