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Generics applications under review by EMA – April 2017 Posted 12/05/2017

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 4 April 2017, the agency is currently reviewing 22 applications for marketing approval in the EU for generics. The applications include one for a generic version of Advagraf/Modigraf (tacrolimus), for which there are already generics approved by EMA for all EU countries, see Table 1. 

Table 1: Generics under review by EMA*

Common name

Therapeutic area

Number of applications

Originator product

Originator company

Anagrelide

Antineoplastic medicine (anticancer)

1

Agrylin/Xagrid

Shire

Buprenorphine/ naloxone

Opioid dependence

1

Suboxone

Indivior

Carglumic acid

Hyperammonaemia in N-acetylglutamate synthase deficiency

1

Carbaglu

Orphan Europe

Carmustine

Chemotherapy

1

BiCNU

Emcure Pharmaceuticals

Darunavir

Antiretroviral (HIV treatment)

1

Prezista

Janssen-Cilag

Efavirenz/ emtricitabine/ tenofovir disoproxil

Antiretroviral (HIV treatment)

2

Atripla

Gilead Sciences/ Bristol-Myers Squibb

Entecavir

Antiviral for hepatitis B virus infection

2

Baraclude

Bristol-Myers Squibb

Febuxostat

Anti-gout medicine

1

Adenuric

Ipsen/ TAP Pharmaceuticals

Fulvestrant

Endocrine therapy (breast cancer)

1

Faslodex

AstraZeneca

Hydrocortisone

Corticosteroid

1

Plenadren

Shire

Lacosamide

Antiepileptic

1

Vimpat

UCB Pharma

Miglustat

Metabolism (Gaucher disease)

1

Zavesca

Actelion

Naloxone

Opioid dependence

1

Narcan

Sankyo

Nitisinone

Hereditary tyrosinemia type 1

2

Orfadin

Swedish Orphan Biovitrum International

Ritonavir

Antiretroviral (HIV treatment)

1

Norvir

AbbVie

Rotigotine

Parkinson’s disease

1

Leganto/Neupro

UCB

Sufentanil

Anaesthetic

1

Sufenta

Janssen Pharmaceutica

Tacrolimus

Immunosuppressant (organ rejection)

1

Advagraf/Modigraf

Astellas

Tigecycline

Antibacterial

1

Tygacil

Pfizer

Total

 

22

   

*Data collected on 12 May 2017
Source: EMA

First-time pan-European generics under review by EMA include one for a generic of Shire’s platelet overproduction medicine Agrylin/Xagrid (anagrelide), one for a generic of Indivior’s opioid treatment Suboxone (buprenorphine/naloxone), 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), two for a generic version of Gilead Sciences HIV treatment Atripla (Efavirenz/emtricitabine/tenofovir disoproxil), one for a generic version of Bristol-Myers Squibb’s hepatitis B virus treatment Baraclude (entecavir), one for a generic version of TAP Pharmaceuticals/Ipsen’s gout treatment Adenuric (febuxostat), one for a generic version of AstraZeneca’s breast cancer treatment Faslodex (fulvestrant), one for a generic version of Shire’s corticosteroid Plenadren (hydrocortisone), one for a generic version of UCB Pharma’s epilepsy medicine Vimpat (Lacosamide), one for generic versions of Actelion’s Gaucher disease treatment Zavesca (miglustat), one for a generic of Sankyo’s opioid treatment Narcan (naloxone), two for a generic version of Swedish Orphan Biovitrum International’s treatment for hereditary tyrosinemia type 1 Orfadin (nitisinone), one for AbbVie’s HIV treatment Norvir (ritonavir), one for a generic version of UCB’s Parkinson’s disease treatment Leganto/Neupro (Rotisgotine), one for a generic version of Janssen Pharmaceutica’s potent opioid anaesthetic Sufenta (sufentanil) and one for a generic of Pfizer’s antibiotic Tygacil (tygecycline).

Since the last report entitled Generics applications under review by EMA – December 2016 by GaBI Online, EMA has approved one 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 generic versions of Actelion’s Gaucher disease treatment Zavesca (miglustat), one for a generic version of Eli Lilly’s carcinoma drug Alimta (pemetrexed), one for a generic version of Pfizer’s antiepileptic Lyrica (pregabalin), 

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Biosimilars applications under review by EMA – December 2016

Generics applications under review by EMA – December 2016

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 12]. 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 2017 May 12] Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU

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Source: EMA

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