First In Line: FDA Vs. EMA Biopharma Approval Times
By Brendan Wang and Christian Thienel, Back Bay Life Science Advisors
The vast majority of biopharma companies place the most emphasis on the U.S. market as the pillar of their business case and commercial strategy. The conventional wisdom is that price potential is significantly larger in the U.S. and the lack of time-intensive healthcare technology assessment (HTA) processes like 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.