In the Part I we had seen which therapeutic areas were covered by approved drugs in EU in 2015 and also how many drugs of special assignments had been approved. Interestingly, more than 77% of new drugs approved in EU in 2015 had been firstly approved in USA. This means that new drugs in EU were not so new to the other world, at least not to USA.
In the current article I will have a look on other interesting facts from the authorised medicinal products in EU in 2015, like the most active companies and manufacturers or where are the Marketing Authorisation Holders (MAH) based or which drugs are the “most copied”.
Marketing authorisation is an act done by European Commission (EC) based on evaluation and recommendation of European Medicines Agency (EMA) and this allows drugs to enter the EU market.
When we look at the most active companies for all drugs authorised in EU in 2015, we see that leaders are Novartis, Amgen and Merck&Co. Novartis had 5 new drugs authorised, Amgen had 4 and Merck&Co 3 new drugs approved in 2015 in EU. Looking at the situation today after MAH transfers, and counting also the Sanofi MSD´s vaccine, Merck&Co is the MAH of 6 drugs approved in 2015, 5 of them are new EU drugs. The change of the MAH for one drug from Cubist to Merck&Co happened beginning of 2016.
Interestingly, the biggest pharma, Pfizer, did not have any EU authorised drug in 2015 on its own. However, after acquiring a generic company in September 2015, Pfizer is a kind “present” in new authorisations with 3 Hospira generics.
The most active orphan drug companies are Alexion and Amgen. Alexion is the MAH for 2 orphan drugs which will be an addition to its Soliris, so far the most expensive drug. These 2 drugs will according to available information not be too much with a price behind this old drug. One drug, Kanuma, was originally authorised for Synageva, however after the $ 8.4 billion deal and the MAH transfer in 2015, Alexion is the MAH for this drug now. Alexion with its Solaris orphan market exclusivity which was extended after obtaining a paediatric reward until 2019 and 2023 for two indications, respectively, will have another two orphan drugs, Kanuma and Strensiq, protected until 2025.
Among the most employed manufacturers, based on official EMA documents, are Novartis Pharma GmbH, Germany; Mylan Hungary Kft, Hungary; Almac Pharma Services Ltd, UK; Amgen Europe B.V, The Netherlands; Lek Pharmaceuticals, d.d, Slovenia and Genzyme Ireland Ltd, Ireland.
Further to orphan drugs, originally there were 18 drugs assigned as orphan drugs but 3 assignments were removed based on request of an MAH. Therefore, the actual number of orphan drugs authorised in EU in 2015 is 15. All except one, are also new active substance medicines (new drugs).
Original MAHs of 41% of all drugs authorised in 2015 to enter the EU market are based in United Kingdom.
This seems to be a consequence of superior tax conditions in UK. The Netherlands is following with less than half of MAHs as in UK. As clearly visible, more than half of EU countries are not present at all.
Until now, I have identified 9 drugs in which the MAH has been changed. Therefore, the current proportion of countries where the MAH is based, is slightly different in comparison to the status at authorisation.
Looking at the generics centrally authorised in 2015 to enter the EU market, it is obvious that the “most copied” drugs are Lyrica, Alimta and Abilify. Both, Lyrica and Abilify, are nervous system drugs, with the active substance pregabalin and aripiprazole, respectively, and Alimta is another pemetrexed used for cancer treatment. Alimta (Eli Lilly) was approved by EC in 2004 similarly to Lyrica (Pfizer) and Abilify (Otsuka).
Companies with the highest number of generics authorised to enter an EU market are classical generic companies like Sandoz (Novartis), Accord Healthcare, Generics, Hospira (now part of Pfizer) and Zentiva. Sandoz has 4 and all other companies mentioned have each 3 generic drugs authorised in 2015 in EU.
I will continue in bringing other interesting facts on the authorised medicinal products in EU in 2015 in some of the following blogs.
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Authorised drugs in EU
For inquiry on detailed analysis with single drugs categorized based on certain parameters and further custom-made analysis from this dataset, please contact us on firstname.lastname@example.org. Examples of other parameters which can be used in analysis include application types (e.g new active substances, fixed combination, etc.), most active companies, most active orphan drug companies and most employed drug manufacturers, chemical subgroup (ATC) categories (e.g monoclonal Abs, protein kinase inhibitors, etc.), closer look on generics (most “copied drugs, most active generics companies), countries where the MAH is based, biologicals type, manufacturing (e.g chemical synthesis, recombinant DNA technology, etc.), organisms used for DNA recombinantly produced drugs, methods of administration and others.