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

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.

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 US Food and Drug Administration (FDA) has approved Sanofi’s Merilog (insulin-aspart-szjj), a biosimilar to Novolog (insulin aspart), for treating adults and children with diabetes.

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 ...