Generics applications under review by EMA – August 2017

Generics/General | Posted 15/09/2017 post-comment0 Post your comment

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].

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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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