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Generics applications under review by EMA – August 2016 Posted 16/09/2016

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 3 August 2016, the agency is currently reviewing 26 applications for marketing approval in the EU for generics. The applications include one for a generic version of Novartis’s schizophrenia drug Cubicin (daptomycin), three for angina treatment ivabradine (Corlanor/Procoralan, Amgen/Servier), one for arthritis treatment methotrexate (Trexall, Pfizer),one for a generic version of Pfizer’s anti-epileptic Lyrica (pregabalin), one for a generic version of Pfizer’s erectile dysfunction drug Viagra (sildenafil) and one for a generic version of Eli Lilly’s erectile dysfunction drug Adcirca/Cialis (tadalafil) 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

Carglumic acid

Hyperammonaemia in N-acetylglutamate synthase deficiency

1

Carbaglu

Orphan Europe

Carmustine

Chemotherapy

1

BiCNU

Emcure Pharmaceuticals

Daptomycin

Anti-bacterial for systemic use

1

Cubicin

Novartis

Darunavir

Anti-retroviral (HIV treatment)

1

Prezista

Janssen-Cilag

Efavirenz/ emtricitabine/ tenofovir disoproxil

Anti-retroviral (HIV treatment)

1

Atripla

Gilead Sciences/ Bristol-Myers Squibb

Emtricitabine/ tenofovir disoproxil

Anti-retroviral (HIV treatment)

3

Truvada

Gilead Sciences

Ertapenem

Anti-bacterial for systemic use

1

Invanz

Merck

Febuxostat

Anti-gout medicine

1

Adenuric

Ipsen/ TAP Pharmaceuticals

Ivabradine

Cardiac therapy (angina)

3

Corlanor/

Procoralan

Amgen/

Servier

Methotrexate

Anti-neoplastic (cancer, arthritis)

1

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

Pregabalin

Anti-epileptic

1

Lyrica

Pfizer

Sildenafil

Erectile dysfunction

2

Viagra

Pfizer

Tadalafil

Erectile dysfunction

1

Adcirca/Cialis

Eli Lilly

Tenofovir disoproxil

Antiretroviral (HIV treatment)

1

Viread

Gilead Sciences

Teriparatide

Osteoporosis

2

Forsteo

Eli Lilly

Tigecycline

Antibacterial

1

Tygacil

Pfizer

Total

 

26

 

 

*Data collected on 2 September 2016
COPD: chronic obstructive pulmonary disease.
Source: EMA

First-time European generics under review by EMA include one for a generic version of Orphan Europe’s amino acid metabolism treatment Carbaglu (carglumic acid), one for a generic version of Emcure Pharmaceuticals chemotherapy drug BiCNU (carmustine), one for a generic version of Janssen-Cilag’s HIV treatment Prezista (darunavir), one for a generic version of Gilead Sciences HIV treatment Atripla (Efavirenz/ emtricitabine/ tenofovir disoproxil ), three for generic versions of Gilead Sciences HIV treatment Truvada (emtricitabine/tenofovir disoproxil), one for a generic version of Merck’s antibiotic Invanz (ertapenem), one for a generic version of TAP Pharmaceuticals/Ipsen’s gout treatment Adenuric (febuxostat), 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), one for a generic of Gilead’s HIV treatment Viread (tenofovir disoproxil), two for generic versions of Eli Lilly’s osteoporosis treatment Forsteo (teriparatide) and one for a generic of Pfizer’s antibiotic Tygacil (tygecycline).

Since the last report entitled ‘Generics applications under review by EMA – April 2016’ by GaBI Online, EMA has approved 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), two for generics of Janssen-Cilag’s multiple myeloma treatment Velcade (bortezomib), one for chemotherapy drug docetaxel (Taxotere, Sanofi), two for GlaxoSmithKline’s asthma and chronic obstructive pulmonary disorder treatment Advair/Seretide (fluticasone/salmeterol), one for a generic of Gilead’s HIV treatment Viread (tenofovir disoproxil)

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Generics applications under review by EMA - April 2016

Biosimilars applications under review by EMA – April 2016

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sept 16]. 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 Sept 16] Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU

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Source: EMA

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