Genetic Engineering & Biotechnology News published an interesting article summarizing some of the points found in comments submitted to FDA in response to its publication of the three draft guidances on biosimilar applications.  All sorts of stakeholders from biological innovators (Genentech and Novo Nordisk) to patient groups to a biosimilar manufacturer (Biocon) leveled criticisms at the Guidances.  We’ll see whether FDA takes any to heart in its final Guidances.