It’s been more than ten years since the FDA signed off on the United States’ first biosimilar product, opening up what was ...

Samsung Bioepis pursues direct sales by weighing Organon acquisition to boost profits Samsung Bioepis weighs buying Organon ...

The FDA approved Nufymco as an interchangeable biosimilar to Lucentis, making it the second approved ranibizumab biosimilar in the U.S. from Formycon and Bioeq, the companies announced in a press ...

A Landmark Regulatory Shift Validates Professor Sarfaraz K. Niazi's Vision to Make Biologics as Affordable as Generics CHICAGO, Oct. 29, 2025 /PRNewswire/ -- In a historic move reshaping global drug ...

Celltrion announced on January 7 that it will present its achievements in new drug development and its future contract manufacturing (CMO) business ...

The FDA has approved Poherdy (pertuzumab-dpzb), the first interchangeable biosimilar to Perjeta (pertuzumab). Poherdy, as approved, is indicated for use in adults with HER2-positive breast cancer, ...

The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to streamline and expedite the biosimilar development process. The regulatory framework has been designed to reduce ...

AEON Biopharma, Inc. announced in its press release that it is advancing its biosimilar development program for ABP-450, a botulinum toxin complex, by initiating analytical studies to prepare for a ...

Industry groups are urging changes to the US Food and Drug Administration’s Biosimilar User Fee Amendments programme as talks ...

(Reuters) -India's Biocon expects a 50% drop in costs for developing complex biosimilars as the United States has proposed to ease clinical testing for the drugs that make up more than 60% of its ...