In recent weeks, we have gathered together the data made publicly available on the state of new drug product approvals in the EU and the US. This report is based on the approval status reported on the FDA and the EMA official websites on March 4th 2015. Although it is always challenging to pull together data from the two regions where classification and reporting styles differ, we have applied some general inclusion criteria to create consistent indicators of the yearly trends between drug approvals in the EU vs the USA. Some of the factors may be of significant strategic importance when deciding on the development path for a new product.

The following summary provides an overview of the key findings and an analysis of what the data(1) actually means for the industry. This data is visually represented in a new infographic, located here.

Equal number of drugs were approved in the US and Europe

Last year, there was a total of 86 new marketing approvals granted in USA and EU together. Of these 86 new products, 52 were approved only in the EU, 53 only in the USA, and 19 were granted in both regions during 2014. 17 drugs approved in the EU in 2014 received approval in 2013, or even earlier in the US, in respect to five products registered in the EU before 2014. It should also be noted that six products that received the approval by the FDA in 2014, have also received positive CHMP opinion during 2014 but are still waiting for the approval of the European Commission. This data implies that both the EMA and the FDA had equally high productivity during 2014. However, the procedure for legal approval in the EU is still somewhat longer, as reported in Center for Innovation in Regulatory Science (CIRS) report from 2013ii. Out of 86 new products, 17 (19.8%) were biologics and the others new chemical entities.

Faster approval in the USA

The CIRS report revealed that drug approval was 174 days faster in the US than in the EU based on the data between 2004 and 2013. 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 programs applied by the two agencies, such as accelerated approvalvi, priority review designation, fast track designation, expedited and conditional approval. We found that of all products that received marketing approval in 2014, 38.4% (33/86) underwent special approval procedures, with FDA granting 27 and EU only ten. The introduction and more frequent use of expedited programs, such as the FDA fast track and breakthrough designations, have had a clear effect on the timeframe for new approvals. This is particularly true for the FDA, where approvals of the new chemical entities hit the second highest year on record for approvals with 41 in 2014 compared to only 29 approvals in 2013iv. In Europe, out of 52 products, 15 received approval for orphan indication in 2014, while in US this number is 14.

Top pharma and infection dominate

The pooled statistics showed that the top pharma companies stood for 61.6% of the MAs last year vs the rest of the industry.iii This corresponded well with last year’s figure of approximately 64%.

Looking at therapeutic areas, the busiest was infection with 23.3% (20/86) of the marketing authorisations granted during 2014, while the approvals in oncology dropped to second place, from 20% in 2013 to 16.3% for 2014. This was followed by the products for endocrine system (14/86) and CNS (9/86). There were three biosimilars approved by EMA in 2014, while FDA granted its first approval for a biosimilar to blinatumomab (Blincyto, Amgen) last year.

NDA supported over 38% in the EU

As reported for 2013, our preliminary analysis for 2014 shows that NDA kept a strong position in supporting the new medicinal products that received approval in Europe. Out of 52 new drugs we supported 20 (38.46%) in various aspects. It is worth mentioning that out of an additional six drugs with a positive CHMP opinion in 2014, with a pending EC decision, we were involved in four procedures.

In summary

Whilst there have been a number of new products approved last year, with some differences between the US and the EU on the number of acceptances, the actual time it took to review new drugs was faster in the USA, many approved products of which had special approval status. Not surprisingly, large pharma continued to lead the way, with infection being the most common therapy area represented, followed by oncology and endocrine products.

NDA had a strong presence in the EU regulatory arena, as we supported over 38% of the new products registered in 2014.

Disclaimer: This report is based on preliminary research figures distilled from the FDA and EMA websites . As experience tells us, the final number of approvals reported normally fluctuate for some time after the end of the year, as the Agencies go through their house keeping processes. There could therefore be some slight changes to the findings outlined in this report before the data is completely finalised.

Notes

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 and duplicate applications from the data.

ii Link to CIRS Report is http://cirsci.org/sites/default/files/R&D%20Briefing%2055%2016122014.pdf

iii The list of the top 50 pharma companies in 2014 was obtained from http://www.currentpartnering.com/

iv http://www.fiercebiotech.com/special-reports/biopharma-posts-chart-topping-41-new-drug-approvals-2014/2015-01-02

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

vi Data on accelerated approval received from EMA via direct communication

The Author

Olga Björnklund

Senior Consultant

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