An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

The FDA has decided that biosimilar medications must have unique naming features, distinguishing them from brand-name biologics in a move to improve patient safety, according to a STAT news report. 1.

Denosumab is a monoclonal antibody that inhibits bone resorption and is widely used across oncology and osteoporosis-related ...

Please provide your email address to receive an email when new articles are posted on . Nufymco is indicated for the treatment of patients with a number of retinal diseases. The VEGF inhibitor is the ...

Samsung Epis Holdings, the new holding company for Samsung Bioepis, is pursuing a bold expansion strategy focused on pipeline ...

Michael Ellenberger, Aydin Harston Ph.D. On October 29, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS) and the Centers for ...

On Wednesday, Oct. 29, the Food and Drug Administration (FDA) issued draft guidance proposing to update its biosimilar review framework. Under the new approach, most biosimilar applications will no ...

Samsung Epis Holdings, the holding company of biosimilar drug developer Samsung Bioepis Co., aims to secure 20 biosimilars in ...

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, ...

Credit: Celltrion Edenzelt is a vascular endothelial growth factor inhibitor. Findings from the phase 3 study showed therapeutic equivalence between the biosimilar and reference product. The Food and ...

With the first biosimilar approved by the US Food and Drug Administration (FDA) in March and a second approval likely in the next few months, practical and operational challenges are already starting, ...