PHARMACEUTICAL ONLINE: 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 emphasize the U.S. market as the pillar of their business case and commercial strategy.

But is the U.S. first in line to access the most innovative pharmaceutical products? 

More than 200 new therapeutics have been approved by the FDA in the last five years, including NDAs and biologics license applications (BLAs). Back Bay Life Science Advisors examined key points around FDA approved products, including: 

• How does the FDA approval date compare to the EMA market authorization date?

• Are there any patterns regarding which products are approved first by the FDA and then by the EMA, and vice versa?

• What implication does this have for biopharma companies as they consider launch sequencing?

By examining these key questions, Back Bay characterizes how frequently the products received U.S. approval ahead of the EU in terms of introduction of novel therapeutics.

Read the article at Pharmaceutical Online or request a download from our team.