The Importance of Safety Aspects in the Amnog Process in Germany: Is the G-Ba Assessment Consistent with That of the CHMP?

Abstract

A483 the assessments with an ASMR I, II or III. 70% (n = 49) of the remaining evaluations where ASMR IV or V. ConClusions: In the first six years mAbs were perceived as a disruptive innovation to a significant proportion of ASMRs between I and III as a reward for research and development efforts of the manufacturer. This research suggest that mAbs manufacturers no longer benefit from a 'first mover' advantage and may face higher scrutiny from the TC and greater price pressure from the French pricing committee.