At the same time, 90% of U.S. prescriptions are either generics or biosimilars saving the U.S. healthcare system $445 billion in 2023 alone. Despite these achievements, there are important reforms ...

Sandoz reported a 9% growth in net sales of generics and biosimilars to third parties for 2024, marking a strong first financial year as an independent company. After completing its spin-off from ...

Amgen has reported positive phase 3 results with its biosimilar version of AstraZeneca/Alexion's blockbuster rare disease drug Soliris, setting up a regulatory filing with the FDA. The biotech has ...

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.

The US FDA has approved the first biosimilar version of AstraZeneca/Alexion’s Soliris therapy for paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic ...

By providing quality-proven biosimilars, we are helping to address a critical healthcare need and reduce the burden of skeletal fractures that impact patients’ quality of life,” said Byoungin ...

Merilog is available in a 3 mL prefilled pen and a 10 mL vial, joining two long-acting insulin biosimilars approved by the FDA in 2021. Merilog, a rapid-acting human insulin analog, is the first ...

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 U.S. Food and Drug Administration approved Merilog as biosimilar to Novolog for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. “Merilog ...

Planegg-Martinsried, Germany - Formycon AG (FSE: FYB, Prime Standard) (“Formycon” or “the Company”) today provided an update on key developments across various biosimilar projects and invites ...

Alvotech (NASDAQ:ALVO) and Teva Pharmaceuticals (NYSE:TEVA) said on Tuesday that the U.S. FDA has accepted for review a Biologics License Application for a biosimilar targeting Regeneron’s (REGN ...

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 ...