Generics applications under review by EMA – 2013 Q1

Generics/General | Posted 29/04/2013 post-comment0 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].

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According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released in March 2013, the agency is currently reviewing 10 applications for marketing approval in the EU for generics. The applications include one for atosiban, one for capecitabine, one for esomeprazole, two for imatinib, two for memantine, and one for levetiracetam, see Table 1.

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

Table 1: Generics under review by EMA*

Common name Therapeutic area Number of applications Originator product Originator company
Atosiban Gynaecologicals (premature labour preventative) 1 Tractocile/Antocin Ferring Pharmaceuticals/ Johnson & Johnson
Capecitabine Antineoplastic medicines (cancer) 1 Xeloda Roche
Esomeprazole Acid-related disorders 1 Nexium AstraZeneca
Imatinib Antineoplastic medicine (cancer) 2 Glivec Novartis
Memantine Psychoanaleptic (Alzheimer’s disease) 2 Axura Ely Lilly
 Merz Pharmaceuticals
Levetiracetam Antiepileptic 1 Keppra UCB Pharmaceuticals
Voriconazole Antimycotic 1 Vfend Pfizer
Zoledronic acid Bone disease 1 Aclasta/Zometa Novartis
Total   10    
*Data collected on 11 April 2013.
Source: EMA

On 16 January 2013, Teva gained EMA approval to market a generic version of Novartis’s pioneering cancer drug Glivec (imatinib) in Europe. The patent for Glivec, however, only runs out in 2016 for Europe and in 2015 for the USA, theoretically giving Novartis some time before competition from generics. The drug had estimated worldwide sales of US$4.72 billion in 2012.

Since the last report by GaBI Online for 2012/Q4, EMA has approved five generics for Alzheimer’s disease treatment memantine and there are two generics applications still under review. This shows the increased interest in dementia. In fact, September 2012 was World Alzheimer’s month, with the theme ‘Dementia: Living together’.

Since 2012/Q4, EMA has also approved two generics applications for blood pressure treatments telmisartan and telmisartan/hydrochlorothiazide.

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1.  GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Apr 29]. Available from:

2.  GaBI Online - Generics and Biosimilars Initiative. Registration procedures for generic drugs in the EU []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Apr 29]. Available from:

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