Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite ...

A Sanofi subsidiary has claimed FDA approval for the first biosimilar of Novo Nordisk's Novolog, an older formulation of the Danish pharma's blockbuster insulin analogue product insulin aspart.

Insulin-aspart-szjj is the first rapid-acting insulin biosimilar approved and the third insulin product approved by the FDA.

The U.S. Food and Drug Administration has approved Sanofi-Aventis's Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with diabetes mellitus.

Samsung Bioepis received approval for two biosimilars of denosumab that are interchangeable with Prolia and Xgeva. Ospomyv provided similar BMD increases as Prolia for women with osteoporosis in a ...