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Generics applications under review by EMA – August 2017 Posted 15/09/2017

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 September 2017, the agency is currently reviewing 24 applications for marketing approval in the EU for generics. The applications include one for a generic version of Glivec (imatinib), one for a generic version of Alimta (pemetrexed) and one for a generic version of Advagraf/Modigraf (tacrolimus), for which there are already generics approved by the 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

Carmustine

Antineoplastic medicine

(anticancer)

1

BiCNU

Emcure Pharmaceuticals

Darunavir

Antiretroviral
 (HIV treatment)

2

Prezista

Janssen-Cilag

Deferiprone

Beta-thalassaemia
 (iron overload)

1

Ferriprox

Apotex

Doxorubicin

Antineoplastic medicine

(anticancer)

1

Caelyx/ Myocet

Janssen-Cilag/Teva

 

Efavirenz/ emtricitabine/ tenofovir disoproxil

Antiretroviral
 (HIV treatment)

1

Atripla

Gilead Sciences/ Bristol-Myers Squibb

Fulvestrant

Endocrine therapy (breast cancer)

1

Faslodex

AstraZeneca

Gefitinib

Antineoplastic medicine

(anticancer)

1

Iressa

AstraZeneca

 

Hydrocortisone

Corticosteroid

 

1

Plenadren

Shire

Imatinib

Antineoplastic medicine

(anticancer)

1

Glivec

Novartis

Lenalidomide

Immunosuppressant
 (multiple myeloma)

1

Revlimid

Celgene

Miglustat

Metabolism
 (Gaucher disease)

1

Zavesca

Actelion

Naloxone

Opioid dependence

1

Narcan

Sankyo

 

Nitisinone

Hereditary tyrosinemia type 1

1

Orfadin

Swedish Orphan Biovitrum International

Paclitaxel

Antineoplastic medicine

(anticancer)

1

Multiple, e.g. Abraxane

Multiple, e.g. Celgene

Pemetrexed

Antineoplastic medicine

(anticancer)

1

Alimta

Eli Lilly

Prasugrel

Antineoplastic medicine

(anticancer)

1

Efient

Daiichi Sankyo

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

Vigabatrin

Antiepileptic

1

Sabril/Sabrilex

Lundbeck

 

Total

 

24

 

 

*Data collected on 15 September 2017
HIV: human immunodeficiency virus.
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 Emcure Pharmaceuticals chemotherapy drug BiCNU (carmustine), two for generic versions of Janssen-Cilag’s HIV treatment Prezista (darunavir), one for a generic version of Apotex’s iron overload in Thalassaemia treatment Ferriprox (deferiprone), one for a generic version of Janssen-Cilag/ Teva’s Caelyx/ Myocet (doxorubicin), one for a generic version of Gilead Sciences HIV treatment Atripla (efavirenz/emtricitabine/tenofovir disoproxil ), one for a generic version of AstraZeneca’s breast cancer treatment Faslodex (fulvestrant), one for a generic version of AstraZeneca’s lung cancer treatment Iressa (gefitinib), one for a generic version of Shire’s corticosteroid Plenadren (hydrocortisone), one for a generic version of Celgene’s Revlimid (lenalidomide), one for generic versions of Actelion’s Gaucher disease treatment Zavesca (miglustat), one for a generic of Sankyo’s opioid treatment Narcan (naloxone), one for a generic version of Swedish Orphan Biovitrum International’s treatment for hereditary tyrosinemia type 1 Orfadin (nitisinone), one for a generic version of Celgene’s Abraxane (paclitaxel), one for a generic version of Daiichi Sankyo’s angina treatment Efient (prasugrel), one for AbbVie’s HIV treatment Norvir (ritonavir), one for a generic version of UCB’s Parkinson’s disease treatment Leganto/Neupro (rotigotine), one for a generic version of Janssen Pharmaceutica’s potent opioid anaesthetic Sufenta (sufentanil) and one for a generic version of Lundbeck’s epilepsy drug Sabril/Sabrilex (vigabatrin).

Since the last report entitled ‘Generics applications under review by EMA – April 2017’ by GaBI Online, EMA has approved one generic version of Orphan Europe’s amino acid metabolism treatment Carbaglu (carglumic acid), one for a generic version of Gilead Sciences HIV treatment Atripla (efavirenz/emtricitabine/tenofovir disoproxil), two for generic versions 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 UCB Pharma’s epilepsy medicine Vimpat (lacosamide), one for a generic version of Swedish Orphan Biovitrum International’s treatment for hereditary tyrosinemia type 1 Orfadin (nitisinone) and one for a generic of Pfizer’s antibiotic Tygacil (tygecycline).

Related articles
Generics applications under review by EMA – April 2017 

Biosimilars applications under review by EMA – April 2017

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 15]. 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 Sep 15] Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU

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Source: EMA

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