Developing an early stage biopharmaceutical asset in Europe: Navigating treacherous waters

A blog post about how manufacturers can create an “Early Asset Success Plan” for new products

When biopharmaceutical products launch in the European Union, even experienced manufacturers can struggle to overcome the demanding standards of European payers. The complex market authorisation requirements and subsequent access decisions across 28 countries can lead to challenging timelines and confusing rollouts. Unfortunately for manufacturers, the future of European commercial planning…

Poster at ISPOR international on the role of indirect comparisons in the AMNOG evaluation procedure

The AMNOG assessment procedure requires that manufacturers submit indirect comparisons for the evaluation of molecules in the absence of the availability of direct comparisons versus the G-BA designated appropriate comparator(s). Although guidelines have been established on how indirect comparisons should be structured and carried out, the methodological robustness sought by…