By Olga Björklund PhD, Senior Consultant, NDA Group
As for the past three years we have gathered the information and analysed the approval statistic across the EU and US. We have reviewed the publicly available data on new drug product approvals based on the approval status reported on the FDA and the EMA official websites on January 26th 2016. As observed in the previous years, it is challenging to pull together data from the two regions where classification and reporting styles differ. We have therefore applied some general inclusion criteria to create consistent indicators of the yearly trends between drug approvals in the EU vs the USA.
The following summary provides an overview of the key findings and an analysis of what the data (i) actually means for the industry. This data is visually represented in a new infographic below.
Equal number of drugs were approved in the US and Europe during 2015, but..
Last year there were a total of 89 new marketing approvals granted in USA and EU together that meet our selection criteria. Of these 89 new products, 32 were approved only in the EU, 34 only in the USA, and 23 were granted in both regions during 2015. Considering the additional 4 products receiving positive CHMP opinion during 2015 but still waiting for the approval of the European Commission, we can conclude that the two Agencies were equally productive during 2015. Out of 89 new products, 25 (28%) were biologics and 64 (72%) new chemical entities, which reflects a considerable increase of biologics compared to the 19.8% approved in 2014 in the two regions.
However, upon further analysis we found that 24 drugs approved in the EU in 2015 received approval in 2014, or even earlier in the US, while only 10 products out of 34 registered in the US in 2015 were approved in the EU before 2015. This is indeed an indicator that applying for approval in the US prior to registration in the EU is still a regular praxis for many companies. In addition, the FDA has a higher rate of granting special approval status through priority review designation (ii), accelerated approval, fast track designation, expedited approval and as introduced in 2015 “The Generating Antibiotics Incentives Now Act” (GAIN Act) through which Avycaz and Cresemba were approved, having a clear effect on shortening the mean approval timelines.
We found that 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 (iii), which is a small increase compared to 2014, but almost doubling compared to 2013 in both regions. FDA has increasingly offered a continuous dialogue to companies throughout development and thereby increased the confidence that the Agency is already familiar with their product by the time of registration. EMA has acknowledged this issue and is trying to encourage pharma industry to seek early interaction via Scientific advice with both the regulatory and health technology assessment (HTA) bodies, as well as interactions with the committee for advanced therapies (CAT). In the first quarter of 2016, EMA is launching a scheme for priority medicines (PRIME), to optimise the development and accelerated assessment of medicines of major public health interest.
Top pharma and oncology dominate
The pooled statistics showed that the top pharma companies stood for 71.9% of the MAs in 2015 vs the rest of the industry (iv). This represents quite an increase compared to around 64% in two previous years implying that the top pharma companies have increased the efforts to acquire companies with promising portfolios but without adequate resources to pull through the late stage development. One could reflect that one of the factors contributing to the growing costs of developing new products lies in often seen divergent approach of the two agencies in assessing risk/benefit profiles. This in turn causes the need for larger clinical trials, label differences and might prevail drugs from entering certain markets. It is therefore not surprising that top pharma, having the means and established networks of distributions, are dominating in the number of approvals in the two regions.
Looking at the therapeutic areas, the busiest was oncology 23.6% (23/89) of the marketing authorisations granted during 2015, while the approvals in infections dropped to second place, from 23.3% in 2014 to 14.6% for 2015. This was 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, while 3 gained approval in 2014.
NDA supported over 50% in the EU
As reported for 2014, our preliminary analysis for 2015 shows that NDA kept a strong position in supporting the new medicinal products that received approval in Europe. Out of 55 new drugs we supported 28 (50.9%) in various aspects.
Whilst the number of new product approvals in 2015 seems to keep an equal pace in both regions, the FDA continued to grant more special approval status compared to the EU. As a consequence the trend persist that many companies first seek approvals in the US as seen in the higher number of drugs already approved in the US before 2015. Top pharma further increased its presence (continued to lead the way), with oncology being the most common therapy area represented, followed by infection and endocrine products.
NDA had a strong presence in the EU regulatory arena, as we supported over 45% of the new products registered from 2013 to 2015.
To read the Press Release click here.
To read the statistics of new drug product approvals from last year click here.
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 fluctuates 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.
(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.
(iv) The list of the top 50 pharma companies in 2015 was obtained from www.currentpartnering.com