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Generics applications under review by EMA – April 2016 Posted 13/05/2016

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 13 April 2016, the agency is currently reviewing 29 applications for marketing approval in the EU for generics. The applications include two for Janssen-Cilag’s multiple myeloma treatment Velcade (bortezomib), one for a generic version of Novartis’s schizophrenia drug Cubicin (daptomycin), one for chemotherapy drug docetaxel (Taxotere, Sanofi), three for angina treatment ivabradine (Corlanor/Procoralan, Amgen/Servier), two for arthritis treatment methotrexate (Trexall, Pfizer), one for a generic version of Pfizer’s erectile dysfunction drug Viagra (sildenafil), one for a generic version of Eli Lilly’s erectile dysfunction drug Adcirca/Cialis (tadalafil) and for which there are already generics approved in the EU, see Table 1.

Table 1: Generics under review by EMA*

Common name

Therapeutic area

Number of applications

Originator product

Originator company

Alendronic acid/colecalciferol

Osteoporosis

1

Fosavance/ Vantavo

MSD

Atazanavir

Anti-retroviral (HIV treatment)

1

Reyataz

Bristol-Myers Squibb

Bortezomib

Anti-neoplastic (multiple myeloma)

2

Velcade

Janssen-Cilag

Daptomycin

Anti-bacterial for systemic use

1

Cubicin

Novartis

Darunavir

Anti-retroviral (HIV treatment)

1

Prezista

Janssen-Cilag

Docetaxel

Anti-neoplastic (chemotherapy)

1

Taxotere

Sanofi Aventis

Emtricitabine/tenofovir disoproxil

Anti-retroviral (HIV treatment)

3

Truvada

Gilead Sciences

Ertapenem

Anti-bacterial for systemic use

1

Invanz

Merck

Fluticasone/salmeterol

Obstructive airway disease (asthma/COPD)

2

Advair/Seretide

GlaxoSmithKline

Ivabradine

Cardiac therapy (angina)

3

Corlanor/Procoralan

Amgen/Servier

Methotrexate

Anti-neoplastic (cancer, arthritis)

2

Maxtrex

Pfizer

Miglustat

Metabolism (Gaucher disease)

1

Zavesca

Actelion

Nitisinone

Hereditary tyrosinemia type 1

1

Orfadin

Swedish Orphan Biovitrum International

Pemetrexed

Anti-neoplastic (carcinoma, lung mesothelioma)

2

Alimta

Eli Lilly

Sildenafil

Erectile dysfunction

2

Viagra

Pfizer

Tadalafil

Erectile dysfunction

1

Adcirca/Cialis

Eli Lilly

Tenofovir disoproxil

Anti-retroviral (HIV treatment)

2

Viread

Gilead Sciences

Teriparatide

Osteoporosis

2

Forsteo

Eli Lilly

Total

 

25

   

*Data collected on 3 May 2016
COPD: chronic obstructive pulmonary disease.
Source: EMA

First-time European generics under review by EMA include one for a generic version of MSD’s osteoporosis treatment Fosavance/Vantavo (alendronic acid/colecalciferol), one for a generic version of Bristol-Myers Squibb’s HIV treatment Reyataz (atazanavir), one for a generic version of Janssen-Cilag’s HIV treatment Prezista (darunavir), three for generic versions of Gilead Sciences HIV treatment Truvada (emtricitabine/tenofovir disoproxil), one for a generic version of Merck’s antibiotic Invanz (ertapenem), two for GlaxoSmithKline’s asthma and chronic obstructive pulmonary disorder treatment Advair/Seretide (fluticasone/salmeterol), one for a generic version of Actelion’s Gaucher disease treatment Zavesca (miglustat), one for a generic version of Swedish Orphan Biovitrum International’s treatment for hereditary tyrosinemia type 1 Orfadin (Nitisinone), two for generic versions of Eli Lilly’s carcinoma drug Alimta (pemetrexed), two for generics of Gilead’s HIV treatment Viread (tenofovir disoproxil) and two for generic versions of Eli Lilly’s osteoporosis treatment Forsteo (teriparatide).

Since the last report entitled ‘Generics applications under review by EMA – August 2015’ by GaBI Online, EMA has approved one for a generic version of high blood pressure treatment Exforge (amlodipine/valsartan) from generics company Mylan, one generic version of Otsuka Pharmaceutical’s schizophrenia drug Abilify (aripiprazole). The agency has also approved a generic version of Merck’s antifungal medication Cancidas (caspofungin), two for generics of Helsinn Birex Pharmaceuticals treatment for chemotherapy-induced nausea and vomiting Aloxi (palonosetron), one for Parkinson’s medicine rasagiline (Azilect, Teva) and one for Eisai’s epilepsy treatment Zonegran (zonisamide).

Related articles
Biosimilars applications under review by EMA – December 2015

Generics applications under review by EMA – December 2015

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 13]. 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 2016 May 13] Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU

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Source: EMA

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