Home / Generics / General / Generics applications under review by EMA – December 2016

Generics applications under review by EMA – December 2016 Posted 20/01/2017

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 2 December 2016, the agency is currently reviewing 20 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) and one for a generic version of Pfizer’s antiepileptic Lyrica (pregabalin), 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

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

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)

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

Ivabradine

Cardiac therapy (angina)

1

Corlanor/

Procoralan

Amgen/

Servier

Lacosamide

Antiepileptic

1

Vimpat

UCB Pharma

Methotrexate

Anti-neoplastic (cancer, arthritis)

1

Maxtrex

Pfizer

Miglustat

Metabolism (Gaucher disease)

2

Zavesca

Actelion

Naloxone

Opioid dependence

1

Narcan

Sankyo

Nitisinone

Hereditary tyrosinemia type 1

1

Orfadin

Swedish Orphan Biovitrum International

Pemetrexed

Anti-neoplastic (carcinoma, lung mesothelioma)

1

Alimta

Eli Lilly

Pregabalin

Antiepileptic

1

Lyrica

Pfizer

Tigecycline

Anti-bacterial

1

Tygacil

Pfizer

Total

 

20

 

 

*Data collected on 19 January 2017

Source: EMA

First-time European generics under review by EMA include 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 UCB Pharma’s epilepsy medicine Vimpat (lacosamide), two 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 Eli Lilly’s carcinoma drug Alimta (pemetrexed) and one for a generic of Pfizer’s antibiotic Tygacil (tygecycline).

Since the last report entitled Generics applications under review by EMA – August 2016 by GaBI Online, EMA has approved three generic versions of Gilead Sciences HIV treatment Truvada (emtricitabine/tenofovir disoproxil), one generic version of Merck’s antibiotic Invanz (ertapenem), two generic versions of angina treatment ivabradine (Corlanor/Procoralan, Amgen/Servier), one generic version of Eli Lilly’s carcinoma drug Alimta (pemetrexed), one generic version of Pfizer’s erectile dysfunction drug Viagra (sildenafil), one generic version of Eli Lilly’s erectile dysfunction drug Adcirca/Cialis (tadalafil), one generic version of Gilead’s HIV treatment Viread (tenofovir disoproxil) and two generic versions of Eli Lilly’s osteoporosis treatment Forsteo (teriparatide).

Related articles
Biosimilars applications under review by EMA – August 2016

Generics applications under review by EMA - August 2016

References
1.   GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 20]. 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 Jan 20] Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2017 Pro Pharma Communications International. All Rights Reserved.

Source: EMA

Comments (0)