Approved drugs in EU in 2015_II

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.

Market authorisation holders (MAH) with the highest number authorisations in 2015 in EU. First number always represents number of all drugs, a number under the slash represents number of new drugs.

Market authorisation holders (MAH) with the highest number authorisations in 2015 in EU. First number always represents number of all drugs, a number under the slash represents number of new drugs.

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).

Country when an original Marketing Authorisation Holder is based at drugs authorised in EU in 2015

Country when an original Marketing Authorisation Holder is based at drugs authorised in EU in 2015


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.

A few facts about generics authorised in EU in 2015

A few facts about generics authorised in EU in 2015

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

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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 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.


Rare diseases and Horizon 2020

What do you think have diseases like Huntington´s disease, Fabry disease, Amyotrophic lateral sclerosis, Fragile X syndrome and cystic fibrosis in common? They belong to rare diseases, diseases that affect no more than 5 people out of 10 000 in EU which means that about 250 000 people maximally are affected by a single disease. However, in most cases there is 1 person in 100 000 affected by a disease. It is therefore not so hard to imagine that this number of patients is not so attractive for drug developers since they reasonably expect that they cannot get returned their investment into a drug development by selling such medicine on this small market.

Just to imagine how many people together are affected by rare diseases- a few numbers from the European Medicine Agency (EMA) webpage: There exist 5000 to 8000 distinct rare diseases, affecting between 27 mil and 36 mil people in EU. Most of the rare diseases are caused by a genetic origin and rest is accounted to degenerative and proliferative causes.

Taken in account that there are a few medicines available and there is a lack of any scientific information about most of the rare diseases, we can see an urgent unmet medical need here and millions of people left without any hope.

Despite predominantly governments are in duty to take care of public health and act in public interest and to provide help also to people with rare diseases, we see numerous initiatives supporting development of orphan drugs funded above all by non-governmental bodies.

On the European level, the European commission via the EMA supports similarly to the Food and Drug administration (FDA), orphan drugs development. In case of the EMA regulatory body, an orphan drug must meet certain criteria:

  • it must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating;
  • the prevalence of the condition in the EU must not be more than 5 in 10,000 or it must be unlikely that marketing of the medicine would generate sufficient returns to justify the investment needed for its development;
  • no satisfactory method of diagnosis, prevention or treatment of the condition concerned can be authorised, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition.

This is quite straightforward definition. Such medicine can then benefit from certain incentives such as protection from competition once on the market (for 10 years) or protocol assistance. There are further incentives for SMEs like reduced fees and administrative and procedural assistance from EMA.

As we will discuss next, in frame of the Horizon 2020, an EU funding program for scientific projects, there have been calls running and in preparation to support development of orphan drugs.

In the past, there have been already some calls within the Horizon 2020 which fully or partly touched rare diseases like PHC-14-2015, FPA-01-2014, SC1-PM-12-2016 or INFRAIA-1-2014-2015. For the open calls, we can mention the NMBP-10-2016 call (Nanoformulation of biologicals) ending in May 2016 and ERN-01-2016 (ERN-2016 – European Reference Networks – Framework Partnership Agreement) with deadline in June 2016 which are partly focused also on rare diseases.

Two forthcoming calls are the most relevant and specifically focused on rare diseases.

The SC1-PM-03-2017 call (Diagnostic characterisation of rare diseases) will be open in July, 29th, 2016 and closed in April, 11th, 2017. Aim of this call is to apply genomics and other –omics or high–throughput approaches for molecular characterization of rare diseases. This is thought to be a large-scale proposal with an expected EU contribution at around 15 mil EUR. The selected proposal shall contribute to the objectives of, and follow the guidelines and policies of the International Rare Diseases Research Consortium IRDiRC (

The second call SC1-PM-08-2017 (New therapies for rare diseases ) is fully dedicated to clinical development of orphan drugs, it is planned to be open in July 2016 and a deadline for the 1st stage is planned to be in October 2016 and for the 2nd stage in April 2017.

There are certain prerequisites to be fulfilled to apply for this call:

1) Orphan designation has been given by the European Commission (via EMA),

2) The proposed clinical trial design takes into account recommendations from protocol assistance given by EMA (The protocol assistance from EMA which is a kind of scientific advice attracts fees. For more details see the EMA web page), and

3) A clear patient recruitment strategy is presented.

Again here, the proposals should follow the guidelines and policies of IRDiRC.

According to the SC1-PM-08-2017 topic description, “the intervention must have been granted the EU orphan designation at the latest on the date of the full proposal call closure”. The whole procedure for orphan drug designation at EMA takes in full about 11,5 months from date of filing (it is also recommended to have free pre-submission meetings with the EMA Orphan Medicines Office and EMA Scientific Advice Office). So, if a drug developer does not have yet an orphan drug designation for a drug to be a part of the SC-1-PM-08-2017 call, it has to be applied at latest in next few days to keep Horizon 2020 timelines. Otherwise this call will be applicable only to drug developers having already the orphan drug designation or being already in process of getting it.

Though drug developers have not had in the past so much interest in orphan drug development, situation is changing due to more factors. An increasing support from EU, governments and non-governmental organizations is one reason. A second factor is that companies can use the orphan drug  as a “lift” for other drugs, e.g targeting the same molecule. Orphan drugs will take advantages of its designation to get incentives and to be on market quicker than a usual drug and to get longer protection and the second-use drug can profit from that. At last, involvement in development of a drug for people left without any hope and even knowing that the direct return of investment will be low or none, can improve public image of pharmaceutical industry and companies involved. None of these reasons is bad and if at the end they improve understanding of rare diseases and can help millions of people, this is something which counts and matters.

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