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Generics applications under review by EMA – April 2015 Posted 05/06/2015

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 for Human Use (CHMP) released on 7 April 2015, the agency is currently reviewing 34 applications for marketing approval in the EU for generics. The applications include one for chemotherapy drug docetaxel (Taxotere, Sanofi), one for arthritis treatment methotrexate (Trexall, Pfizer) and one for Parkinson’s medicine rasagiline (Azilect, Teva), for which there are already generics approved in the EU, see Table 1.

According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use (CHMP) released on 7 April 2015, the agency is currently reviewing 34 applications for marketing approval in the EU for generics. The applications include one for anti-fungal medication voriconazole (Pfizer’s Vfend), 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

Amlodipine/ valsartan

Renin-angiotensin (high blood pressure)

1

Exforge

Novartis

Aripiprazole

Psycoleptic (schizophrenia)

5

Abilify

Otsuka Pharmaceutical

Atazanavir

Anti-retroviral (HIV treatment)

1

Reyataz

Bristol-Myers Squibb

Bortezomib

Antineoplastic (multiple myeloma)

2

Velcade

Janssen-Cilag

Caspofungin 

Antimycotic (antifungal)

1

Cancidas

Merck

Cinacalcet

Calcium homeostasis

1

Mimpara

Amgen

Docetaxel

Antineoplastic (chemotherapy)

1

Taxotere

Sanofi

Duloxetine

Psychoanaleptic (anxiety, depression)

3

Cymbalta

Eli Lilly

Eptifibatide

Antithrombotic (blood-clot prevention)

1

Integrilin

GlaxoSmithKline

Lopinavir/ ritonavir

Anti-retroviral (HIV treatment)

1

Kaletra

AbbVie

Methotrexate

Antineoplastic (cancer, arthritis)

1

Maxtrex

Pfizer

Miglustat

Metabolism (Gaucher disease)

1

Zavesca

Actelion

Pemetrexed

Antineoplastic (carcinoma, lung mesothelioma)

7

Alimta

Eli Lilly

Pregabalin 

Antiepileptics

6

Lyrica

Pfizer

Rasagiline

Parkinson’s disease

1

Azilect

Teva Pharmaceutical Industries

Sufentanil

Anaesthetics

1

Sufenta

Janssen Pharmaceutica

Total

 

34

 

 

*Data collected on 4 June 2015.
Source: EMA

First-time European generics under review by EMA include one for a generic version of high blood pressure treatment Exforge (amlodipine/valsartan), five for generics of Otsuka Pharmaceutical’s schizophrenia drug Abilify (aripiprazole), one for a generic version of Bristol-Myers Squibb’s anti-retroviral HIV treatment Reyataz (atazanavir), two for generic versions of Janssen-Cilag’s multiple myeloma treatment Velcade (bortezomib), one for a generic version of Merck’s antifungal medication Cancidas (caspofungin), one for a generic version of Amgen’s treatment for high calcium levels Mimpara (cinacalcet), three for generics of Eli Lilly’s anxiety/depression treatment Cymbalta (duloxetine), one for a generic version of GlaxoSmithKline’s heart-attack prevention Intergrilin (eptifibatide), one for AbbVie’s HIV treatment Kaletra (lopinavir/ritonavir), one for a generic version of Actelion’s Gaucher disease treatment Zavesca (miglustat), seven for generics of Eli Lilly’s carcinoma drug Alimta (pemetrexed), six for generics of Pfizer’s epilepsy treatment Lyrica (pregabalin) and one for a generic version of Janssen Pharmaceutica’s potent opioid anaesthetic Sufenta (sufentanil).

Since the last report entitled ‘Generics applications under review by EMA – December 2014’ by GaBI Online, EMA has approved a generic version of Pfizer’s anti-fungal medication Vfend (voriconazole).

Related article
Biosimilars applications under review by EMA – April 2015

Generics applications under review by EMA – December 2014

References
1.   GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 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 2015 Jun 5] Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU

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Source: EMA

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