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 April 2017, the agency is currently reviewing 22 applications for marketing approval in the EU for generics. The applications include one for a generic version of Advagraf/Modigraf (tacrolimus), 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	Originator product	Originator company
Anagrelide	Antineoplastic medicine (anticancer)	1	Agrylin/Xagrid	Shire
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
Darunavir	Antiretroviral (HIV treatment)	1	Prezista	Janssen-Cilag
Efavirenz/ emtricitabine/ tenofovir disoproxil	Antiretroviral (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
Fulvestrant	Endocrine therapy (breast cancer)	1	Faslodex	AstraZeneca
Hydrocortisone	Corticosteroid	1	Plenadren	Shire
Lacosamide	Antiepileptic	1	Vimpat	UCB Pharma
Miglustat	Metabolism (Gaucher disease)	1	Zavesca	Actelion
Naloxone	Opioid dependence	1	Narcan	Sankyo
Nitisinone	Hereditary tyrosinemia type 1	2	Orfadin	Swedish Orphan Biovitrum International
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
Tigecycline	Antibacterial	1	Tygacil	Pfizer
Total		22
*Data collected on 12 May 2017 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 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 AstraZeneca’s breast cancer treatment Faslodex (fulvestrant), one for a generic version of Shire’s corticosteroid Plenadren (hydrocortisone), one for a generic version of UCB Pharma’s epilepsy medicine Vimpat (Lacosamide), one for generic versions of Actelion’s Gaucher disease treatment Zavesca (miglustat), one for a generic of Sankyo’s opioid treatment Narcan (naloxone), two for a generic version of Swedish Orphan Biovitrum International’s treatment for hereditary tyrosinemia type 1 Orfadin (nitisinone), one for AbbVie’s HIV treatment Norvir (ritonavir), one for a generic version of UCB’s Parkinson’s disease treatment Leganto/Neupro (Rotisgotine), one for a generic version of Janssen Pharmaceutica’s potent opioid anaesthetic Sufenta (sufentanil) and one for a generic of Pfizer’s antibiotic Tygacil (tygecycline).

Since the last report entitled Generics applications under review by EMA – December 2016 by GaBI Online, EMA has approved one 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), one for generic versions of Actelion’s Gaucher disease treatment Zavesca (miglustat), one for a generic version of Eli Lilly’s carcinoma drug Alimta (pemetrexed), one for a generic version of Pfizer’s antiepileptic Lyrica (pregabalin),

Generics applications under review by EMA – December 2016

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 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 2017 May 12] 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.

Source: EMA