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 June 2013, the agency is currently reviewing eight applications for marketing approval in the EU for generics. The applications include one for esomeprazole, one for imatinib, one for levetiracetam and one for memantine, see Table 1.
First-time European generics under review by EMA include one for a generic version of AstraZeneca’s chronic obstructive pulmonary disease treatment Symbicort (budesonide/formoterol), one for Roche’s flu treatment Tamiflu (oseltamivir), one for a generic version of Advagraf/Modigraf (tacrolimus), made by Astellas; and one for a generic version of bone cancer treatment Aclasta/Zometa (zoledronic acid), made by Novartis.
Table 1: Generics under review by EMA*
| Common name
|
Therapeutic area
|
Number of applications
|
Originator product
|
Originator company
|
Budesonide/
formoterol
|
Obstructive airway diseases
|
1
|
Symbicort
|
AstraZeneca
|
| Esomeprazole
|
Acid-related disorders
|
1
|
Nexium
|
AstraZeneca
|
| Imatinib
|
Antineoplastic medicine (cancer)
|
1
|
Glivec
|
Novartis
|
| Levetiracetam
|
Antiepileptic
|
1
|
Keppra
|
UCB Pharmaceuticals
|
| Memantine
|
Psychoanaleptic (Alzheimer’s disease)
|
1
|
Axura
|
Ely Lilly
Merz Pharmaceuticals
|
| Oseltamivir
|
Antiviral
(flu treatment)
|
1
|
Tamiflu
|
Genentech (Roche)
|
| Tacrolimus
|
Immunosuppressant
(organ rejection)
|
1
|
Advagraf/Modigraf
|
Astellas
|
| Zoledronic acid
|
Bone disease
|
1
|
Aclasta/Zometa
|
Novartis
|
| Total
|
|
8
|
|
|
*Data collected on 5 July 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 US, 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 2013 Q1, EMA has approved yet another generic drug for Alzheimer’s disease treatment memantine, on top of the five approvals at the end of 2012, and leaving one generics application 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 2013 Q1, EMA has also approved atosiban and capecitabine generics from Sun Pharmaceutical Industries and a generic version of voriconazole from Accord Healthcare.
Related articles
Biosimilars applications under review by EMA – 2013 Q2
Generics applications under review by EMA – 2013 Q1
References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jul 5]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-generics
2. GaBI Online - Generics and Biosimilars Initiative. Registration procedures for generic drugs in the EU [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jul 5]. Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU
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