Last update: 4 October 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 the EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released on 5 September 2013, the agency is currently reviewing eight applications for marketing approval in the EU for generics. The applications include 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 a generic version of Otsuka Pharmaceutical’s Busulfex (busulfan), one for Roche’s flu treatment Tamiflu (oseltamivir), one for a generic version of Advagraf/Modigraf (tacrolimus), made by Astellas; and two for generic versions 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
|
| Busulfan
|
Haematopoietic stem cell transplantation
|
1
|
Busulfex/Busilvex
|
Otsuka Pharmaceutical
|
| 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
|
2
|
Aclasta/Zometa
|
Novartis
|
| Total
|
|
8
|
|
|
*Data collected on 3 October 2013.
Source: EMA
|
On 2 August 2013, EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for an imatinib generic, Imatinib medac, produced by German oncology/haematology specialist Medac.
Since the last report by GaBI Online for 2013 Q2, EMA has removed generic esomeprazole from its list, however, no authorization has appeared on the agency’s website, leading GaBI Online to believe that this application has been withdrawn.
Related articles
Biosimilars applications under review by EMA – 2013 Q3
Generics 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 Oct 4]. 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 Oct 4]. Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU
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