Sue Schniepp, Chair, PDA Regulatory and Quality Advisory Board, and Hal Basemen, Chair, PDA, speak with BioPharm International.

An advisory panel deemed Amgen’s Repatha (evolocumab) to be safe overall.

Physician confidence in biosimilars and extrapolation of indications are two of the most important factors governing the acceptance and sustainability of biosimilars, say industry panelists.

FDA concludes Orkambi demonstrates a clinical benefit over placebo, but questions the magnitude of the improvement.