NDA Group releases data comparing FDA and EMA ahead of annual DIA EuroMeeting in Hamburg

In spite of similar approval numbers, the US continue to outpace Europe.

This year's report — based on preliminary research figures distilled from the FDA and EMA websites on 26 January 2016 — found that FDA and EMA were equally productive in 2015, with a total of 89 new approvals granted. However, while 34 of those approvals came from the US and 32 in the EU, 24 drugs approved in the EU in 2015 had received prior approval in the US, while only 10 products out of 34 registered in the US in 2015 were previously approved in the EU.

"Understanding the needs and requirements of regional or even local stakeholders has become critical for biopharmaceutical companies looking to achieve a product's full market potential," said Johan Strömquist, CEO, NDA Group. "Integrating these requirements and developing strategies and plans to successfully meet them is at the heart of what we do at NDA. The differences between the two regions are natural given history, procedures and available regulatory pathways. The gap is however unnecessary and by bridging it companies would get the benefits of market presence in the world's two largest markets. Critically, addressing this would provide patients on both continents access to important medical therapies faster."

Olga Björklund, NDA's Senior Consultant behind the research commented: "The findings released today indicate that drug development companies generally prefer to apply for approval in the US before pursuing the EU. Additionally, the FDA has a higher rate of granting special approval status through priority review designation, accelerated approval, fast track designation, and expedited approval. It is expected that with the EMA's initiatives, such as early interactions between regulatory and health technology assessment bodies, interactions with committee for advanced therapies and the recent launch of the scheme for priority medicines (PRIME) there will be a noticeable impact on the approval statistics in Europe."

Of all new products that received marketing approval in 2015, 41.6% (37/89) underwent special approval procedures, with FDA granting 27 and EU 13, which is a small increase compared to 2014, but almost double the number from 2013 in both regions.

As for therapeutic areas, the busiest was oncology, with 23.6% (23/89) of the marketing authorizations granted during 2015. Approvals in infections dropped to second place, from 23.3% in 2014 to 14.6% for 2015. Those were followed by the products for endocrine system (12/89), cardiovascular (9/89) and respiratory system (9/89). Filgrastrim Sandoz was the only biosimilar to be approved in the US in 2015 (approved in the EU in 2009). In the EU no new approvals for biosimilars were granted in 2015, though 3 gained approval in 2014.