Generics applications under review by EMA

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 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).

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

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Source: EMA