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

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

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 ...

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

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 ...

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

LAKE ZURICH, Ill., March 27, 2025--(BUSINESS WIRE)--Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence ® (denosumab-bnht) and Bomyntra ...

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

Milan Kalawadia, CEO, North America, at Dr. Reddy’s Laboratories, goes inside the company’s new growth initiatives—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 ...