Generics applications under review by EMA – January 2018

Generics/General | Posted 12/01/2018 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].

EMA logo 2 V13F14

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 January 2018, the agency is currently reviewing 13 applications for marketing approval in the EU for generics. The applications include one for a generic version of Alimta (pemetrexed), 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 EMA-approved originator(s) Originator company(ies)
Buprenorphine Opioid dependence 1 Suboxone Indivior
Carmustine

Antineoplastic medicine

(anticancer)

1 BiCNU Emcure Pharmaceuticals
Deferiprone beta-thalassaemia
 (iron overload)
1 Ferriprox Apotex
Doxorubicin

Antineoplastic medicine

(anticancer)

1 Caelyx/Myocet

Janssen-Cilag/Teva

 

Gefitinib

Antineoplastic medicine

(anticancer)

1 Iressa

AstraZeneca

 

Lenalidomide Immunosuppressant
 (multiple myeloma)
1 Revlimid Celgene
Nitisinone Hereditary tyrosinemia type 1 1 Orfadin Swedish Orphan Biovitrum International
Paclitaxel

Antineoplastic medicine

(anticancer)

1 Abraxane Celgene
Pemetrexed

Antineoplastic medicine

(anticancer)

1 Alimta Eli Lilly
Prasugrel

Antineoplastic medicine

(anticancer)

1 Efient Daiichi Sankyo
Rotigotine Parkinson’s disease 1 Leganto/Neupro UCB
Sufentanil Anaesthetic 1 Sufenta Janssen Pharmaceutica
Vigabatrin Anti-epileptic 1 Sabril/Sabrilex

Lundbeck

 

Total   13    

*Data collected on 12 January 2018.

Source: EMA

First-time pan-European generics under review by EMA include one for a generic of Indivior’s opioid treatment Suboxone (buprenorphine), one for a generic version of Emcure Pharmaceuticals chemotherapy drug BiCNU (carmustine), 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 AstraZeneca’s lung cancer treatment Iressa (gefitinib), one for a generic version of Celgene’s Revlimid (lenalidomide), 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 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 of Lundbeck’s epilepsy drug Sabril/Sabrilex (vigabatrin).

EMA’s CHMP announced on 12 October 2017 the approval for a generic version of organ-rejection treatment tacrolimus [3]. And on 18 October 2012, the CHMP also recommended approval of a generic version of anticancer medicine imatinib [4].

Since the last report entitled ‘Generics applications under review by EMA – August 2017’ by GaBI Online, EMA has approved one generic version of Shire’s platelet overproduction medicine Agrylin/Xagrid (anagrelide), two for generic versions of Janssen-Cilag’s HIV treatment Prezista (darunavir), 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 Shire’s corticosteroid Plenadren (hydrocortisone), one for generic versions of Actelion’s Gaucher disease treatment Zavesca (miglustat), one for a generic of Sankyo’s opioid treatment Narcan (naloxone), and one for AbbVie’s HIV treatment Norvir (ritonavir).

Related articles
Biosimilars applications under review by EMA – January 2018

Generics applications under review by EMA – August 2017

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 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 2018 Jan 12] Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU
3. GaBI Online - Generics and Biosimilars Initiative. EMA approval for tacrolimus generic [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 12] Available from: www.gabionline.net/Generics/News/EMA-approval-for-tacrolimus-generic
4. GaBI Online - Generics and Biosimilars Initiative. EMA approves first generic imatinib [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 12] Available from: www.gabionline.net/Generics/General/EMA-approves-first-generic-imatinib

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 © 2018 Pro Pharma Communications International. All Rights Reserved.

Source: EMA

comment icon Comments (0)
Post your comment
Related content
Generic drug growth in Brazil and Venezuela
53 MD002445
Generics/General Posted 15/09/2023
Pharmaceutical manufacturing companies in Brazil
91 AA007225
Generics/General Posted 26/08/2022
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010