Generics applications under review by EMA

Generics/General | Posted 05/10/2012 post-comment2 Post your comment

Last update:  6 September 2013

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 27 EU member states and in Norway, Iceland and Liechtenstein. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].


According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released in September 2012 the agency is currently reviewing 18 applications for marketing approval in the EU for generics. The applications include two for capecitabine, one for esomeprazole, one for ibandronic acid, three for imatinib, six for memantine, one for telmisartin, one for telmisartan/hydrochlorothiazide, see Table 1.

First-time European generics under review by EMA include one for a generic version of Pfizer’s antimycotic Vfend (voriconazole) and two for Novartis’s bone cancer treatment Aclasta/Zometa (zoledronic acid).

Table 1: Generics under review by EMA*

Generic name Therapeutic area Number of applications Originator product Originator company
Capecitabine Antineoplastic medicines (cancer) 2 Xeloda Roche
Esomeprazole Acid-related disorders 1 Nexium AstraZeneca
Ibandronic acid Bone disease 1 Bondronat Roche
Imatinib Antineoplastic medicine (cancer) 3 Glivec Novartis
Memantine Psychoanaleptic (Alzheimer’s disease) 6 Axura Ely Lilly
Merz Pharmaceuticals
Telmisartan Reninangiotensin system (blood pressure treatment) 1 Pritor/Kinzal Bayer
Telmisartan / hydrochlorothiazide Reninangiotensin system (blood pressure treatment) 1 - -
Voriconazole Antimycotic 1 Vfend Pfizer
Zoledronic acid Bone disease 2 Aclasta/Zometa Novartis
Total   18    
*Data collected on 27 September 2012
Source: EMA

The patent for Novartis’s pioneering cancer drug Glivec (imatinib), on the other hand, only runs out in 2016 for Europe and in 2015 for the USA, this will give Novartis some time before competition from generics. The drug had worldwide sales in 2011 of US$1.51 billion.

The fact that there are six generics applications under review for Alzheimer’s disease treatment memantine shows the increased interest of pharma in dementia. In fact, September 2012 was World Alzheimer’s Month, with the theme ‘Dementia: Living together’.

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1.  GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 5]. Available from:

2.  GaBI Online - Generics and Biosimilars Initiative. Registration procedures for generic drugs in the EU []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Dec 4]. Available from: 

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Source: EMA

comment icon Comments (2)
Post your comment
Posted 22/01/2013 by Jodi H, GaBI Online Editorial Office
Response to ‘Generic applications under review at EMA’

Dear Mr Ross,
Thank you for your comment. Please note that on 11 January 2013, we updated the content of this article for better clarification.
Best regards,

Posted 05/10/2012 by Malcolm Ross
Generic applications under review at EMA

I suspect that the article is confusing in that it implies that there are only two mechanisms for approval, Central and National whereas the major pathways for generics are in fact DCP and MRP

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