Novartis' soon-to-be-divested Sandoz unit has positive clinical trial data in hand for a biosimilar of Amgen's blockbuster osteoporosis therapy Prolia (denosumab), clearing the way for regulatory ...

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.

It calls the new drug “Merilog,” a biosimilar to the widely-used insulin product Novolog (insulin aspart). A biosimilar is highly similar to that reference with no clinically meaningful ...

The FDA has approved Merilog (insulin-aspart-szjj), a biosimilar to Novolog (insulin aspart), for improving glycemic control in adults and pediatric patients with diabetes mellitus. The regulatory ...

2,3 OSPOMYV and XBRYK, marks Samsung Bioepis’ 9 th and 10 th FDA approved medicines as well as the company’s first FDA approval for an endocrinology biosimilar, setting another milestone for ...