First In Line: FDA Vs. EMA Biopharma Approval Times

By Brendan Wang & Christian Thienel

The majority of biopharma companies emphasize the U.S. market as the pillar of their business case and commercial strategy. Conventional wisdom is that price potential is significantly higher in the U.S., and the lack of time-intensive healthcare technology assessment (HTA) processes such as those seen in Europe are the key drivers of this phenomenon. However, often lost in this discussion is whether the regulatory agencies themselves have a major impact — namely whether there is any difference in approval timelines between the FDA and EMA.