By Olga Björklund PhD, Senior Consultant, NDA Group

Over the past couple of months we’ve researched data on the state of new drug product approvals in the EU and the US. Our findings were recently published in an Infographic. The aim with our research was to identify the similarities and differences between drug approvals in the EU vs the USA – factors that may be of significant strategic importance when deciding on the development path for a new product. This commentary is an overview of the key findings and what the data[i] actually means for the industry.

[i]The data was gathered from the EMA and FDA official websites, concerning the drug approvals for new active substances (chemical, biological, biotechnology or radiopharmaceutical substance), new biological entity, new drug combination, biosimilars, new active ingredient and vaccines, excluding only generic applications from the data.

FINDING: IN 2013 THE EMA APPROVED MORE NEW DRUGS THAN THE FDA, BUT…

Last year there was a total of 84 new marketing approvals granted throughout the year. Of these 84 new products, 60 products were approved in the EU; 40 in the USA; and 16 were granted in both regions. However, even though it appears from these numbers that the EMA had a better output during 2013, it should be noted that 20 of the drug products had already been authorised by the FDA (14 of them during 2012 and 6 in the previous years). Even though one of the products approved by the FDA last year had already been approved in Europe through the de-centralised procedure, the productivity of both Agencies in terms of new drug approvals were a lot more even than the statistics might first give the impression of.

FINDING: DRUGS GET APPROVED FASTER IN THE USA

Recently, the Center for Innovation in Regulatory Science (CIRS) released a report[ii] concerning new drug approvals in ICH countries between 2004 and 2013. They found that drug approval was 174 days faster in the US than in the EU during 2013[iii]. This timeline was expressed as the median approval time for product from submission to the date of approval by the Agency.

In order to understand some of the reasons for this substantial difference in the approval timelines we compared the frequency of the application of new review programsapplied by the two agencies, such as accelerated approval, priority review designation, fast track designation, expedited and conditional approval. We found that of all products that received marketing approval in 2013, 23.8% (20/84) had been granted special approval status, with FDA granting 16 and EU only seven. The introduction and more frequent use of expedited designations have had a clear effect on the time frame for new approvals, particularly in the US. It also explains part of the significant difference in approval times between the two regions.

FINDING: HIGH ORPHAN DRUG DESIGNATION APPROVALS

We also found that 15 products received marketing approval for drugs with orphan drug designation, 10 in EU and 13 in US, with eight products receiving ODD status in both regions. It will be of interest to monitor what effect the EMA effort to implement Adaptive Licensing will have on the EU approvals’ statistics in the upcoming years. However, it should always be kept in mind the difference in organisation and timelines between the FDA, handling one country, vs the EU, with multinational procedures and timelines.

FINDING: TOP PHARMA COMPANIES AND ONCOLOGY DOMINATE MA APPROVALS

The pooled statistics showed that the top pharma companies stood for 64% of the MAs last year vs the rest of the industry.[iv]

Looking at therapeutic areas, the busiest was oncology with more than 20% (18/84) of the marketing authorisations granted during 2013. This was followed by the products for CNS (10/84) and endocrine system (10/84). While the FDA accounted for faster approval timelines, EMA showed to be more open in granting approvals to biosimilars.[v]

IN SUMMARY

Whilst there have been a number of new products approved last year, with differences between US and the EU on the number of acceptances, the actual timing was much faster in the USA, many of which had special approval status. Not surprisingly, large pharma led the way, with oncology being the most frequent, followed by CNS and endocrine products, with the EU in particular being more open to biosimilars.

It will be interesting to track how these findings trend over the next few years, to really get a true insight into developments.

 

[i]The data was gathered from the EMA and FDA official websites, concerning the drug approvals for new active substances (chemical, biological, biotechnology or radiopharmaceutical substance), new biological entity, new drug combination, biosimilars, new active ingredient and vaccines, excluding only generic applications from the data.

[ii] Link to CIRS Report is here

[iii]It should be noted that the CIRS rapport data did not include the data on vaccines.

[iv]The list of the top 50 pharma companies in 2013 was obtained from the “Current Partnering” website.

[v]It should be noted that for several products it was hard to gain adequate information on agency websites.

The Author

Olga Björnklund

Senior Consultant

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