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 28 European Union (EU) Member States and in Iceland, Liechtenstein, and Norway. 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 (CHMP) for Human Use released on 8 September 2014, the agency is currently reviewing 21 applications for marketing approval in the EU for generics. The applications include one for blockbuster blood-clot treatment clopidogrel (Bristol-Myers Squibb/Sanofi’s Plavix), one for anti-fungal medication voriconazole (Pfizer’s Vfend) and one for chemotherapy drug docetaxel (Taxotere – made by Aventis), for which there are already generics approved by EMA, see Table 1.
Table 1: Generics under review by EMA*
| Common name
|
Therapeutic area
|
Number of applications
|
Originator product
|
Originator company
|
| Aripiprazole
|
Psycoleptics (schizophrenia)
|
5
|
Abilify
|
Otsuka Pharmaceutical
|
| Bortezomib
|
Antineoplastic (multiple myeloma)
|
1
|
Velcade
|
Janssen-Cilag
|
Budesonide/
formoterol
|
Obstructive airway diseases
|
3
|
Symbicort
|
AstraZeneca
|
| Busulfan
|
Haematopoietic stem cell transplantation
|
1
|
Busulfex/Busilvex
|
Otsuka Pharmaceutical
|
| Clopidogrel
|
Antithrombotic medicines
|
1
|
Plavix
|
Bristol-Myers Squibb/Sanofi
|
| Docetaxel
|
Antineoplastic medicines
|
1
|
Taxotere
|
Aventis
|
| Pregabalin
|
Antiepileptics
|
6
|
Lyrica
|
Pfizer
|
| Sufentanil
|
Anaesthetics
|
1
|
Sufenta
|
Janssen Pharmaceutica
|
| Tadalafil
|
Urologicals
|
1
|
Cialis
|
Eli Lilly
|
| Voriconazole
|
Antimycotic
|
1
|
Vfend
|
Pfizer
|
| Total
|
|
21
|
|
|
*Data collected on 16 September 2014.
Source: EMA
|
On 18 July 2014, a tacrolimus generic (Envarsus), produced by Chiesi Farmaceutici received marketing authorization for the EU. The generic drug is indicated for the prevention of organ rejection. There are now three different tacrolimus drugs (including the originator Advagraf/Modigraf) approved by EMA for use in the EU to prevent organ rejection. The brand-name drug Protopic (tacrolimus) is also approved by EMA for use in the EU to treat atopic dermatitis (eczema).
First-time European generics under review by EMA include five for generics of Otsuka Pharmaceutical’s schizophrenia drug Abilify (Aripiprazole), one for a generic version of Janssen-Cilag’s multiple myeloma treatment Velcade (bortezomib), three for generic versions of AstraZeneca’s chronic obstructive pulmonary disease treatment Symbicort (budesonide/formoterol), one for a generic version of Otsuka Pharmaceutical’s stem cell transplantation drug Busulfex (busulfan), six for a generic version of Pfizer’s epilepsy treatment Lyrica (pregabalin), one for a generic version of Janssen Pharmaceutica’s potent opioid anaesthetic Sufenta (sufentanil) and one for a generic version of Eli Lilly’s erectile dysfunction drug Cialis (tadalafil).
Related Articles
Biosimilars applications under review by EMA – April 2014
Generics applications under review by EMA – April 2014
Clopidogrel goes off-patent: last of the old-style blockbusters
References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 19]. 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 2014 Sep 19] Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU
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