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 December 2015, the agency is currently reviewing 25 applications for marketing approval in the EU for generics. The applications include one for a generic version of Otsuka Pharmaceutical’s schizophrenia drug Abilify (aripiprazole), two for Janssen-Cilag’s multiple myeloma treatment Velcade (bortezomib), one for chemotherapy drug docetaxel (Taxotere, Sanofi), two for arthritis treatment methotrexate (Trexall, Pfizer) and one for Parkinson’s medicine rasagiline (Azilect, Teva), 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
Alendronic acid/colecalciferol	Osteoporosis	1	Fosavance/Vantavo	MSD
Amlodipine/valsartan	Renin-angiotensin (high blood pressure)	1	Exforge	Novartis
Aripiprazole	Psycoleptic (schizophrenia)	1	Abilify	Otsuka Pharmaceutical
Atazanavir	Antiretroviral (HIV treatment)	1	Reyataz	Bristol-Myers Squibb
Bortezomib	Antineoplastic (multiple myeloma)	2	Velcade	Janssen-Cilag
Caspofungin	Antimycotic (antifungal)	1	Candidas	Merck
Darunavir	Antiretroviral (HIV treatment)	1	Prezista	Janssen-Cilag
Docetaxel	Antineoplastic (chemotherapy)	1	Taxotere	Sanofi-Aventis
Emtricitabine/tenofovir disoproxil	Antiretroviral (HIV treatment)	2	Truvada	Gilead Sciences
Ertapenem	Antibacterial for systemic use	1	Invanz	Merck
Fluticasone/salmeterol	Obstructive airway disease (asthma/COPD)	2	Advair/Seretide	GlaxoSmithKline
Ivabradine	Cardiac therapy (angina)	1	Corlanor/Procoralan	Amgen/Servier
Methotrexate	Antineoplastic (cancer, arthritis)	2	Maxtrex	Pfizer
Miglustat	Metabolism (Gaucher disease)	1	Zavesca	Actelion
Palonosetron	Anti-emetic/anti-nauseant (prevention of chemotherapy-induced nausea and vomiting)	2	Aloxi	Helsinn Birex Pharmaceuticals
Pemetrexed	Antineoplastic (carcinoma, lung mesothelioma)	1	Alimta	Eli Lilly
Rasagiline	Parkinson’s disease	1	Azilect	Teva Pharmaceutical Industries
Tenofovir disoproxil	Antiretroviral (HIV treatment)	2	Viread	Gilead Sciences
Zonisamide	Anti-epileptic	1	Zonegran	Eisai
Total		25
*Data collected on 29 January 2016. COPD: chronic obstructive pulmonary disease. Source: EMA

First-time European generics under review by EMA include one for a generic version of MSD’s osteoporosis treatment Fosavance/Vantavo (alendronic acid/colecalciferol), one for a generic version of high blood pressure treatment Exforge (amlodipine/valsartan), one for a generic version of Bristol-Myers Squibb’s HIV treatment Reyataz (atazanavir), one for a generic version of Merck’s antifungal medication Cancidas (caspofungin), one for a generic version of Janssen-Cilag’s HIV treatment Prezista (darunavir), one for a generic version of Gilead Sciences HIV treatment Truvada (emtricitabine/tenofovir disoproxil), two for GlaxoSmithKline’s asthma and chronic obstructive pulmonary disorder treatment Advair/Seretide (fluticasone/salmeterol), one for a generic version of Actelion’s Gaucher disease treatment Zavesca (miglustat), two for generics of Helsinn Birex Pharmaceuticals treatment for chemotherapy-induced nausea and vomiting Aloxi (palonosetron), one for a generic version of Eli Lilly’s carcinoma drug Alimta (pemetrexed), two for generics of Gilead’s HIV treatment Viread (tenofovir disoproxil) and one for Eisai’s epilepsy treatment Zonegran (zonisamide).

Since the last report entitled Generics applications under review by EMA – August 2015 by GaBI Online, EMA has approved one generic version of Otsuka Pharmaceutical’s schizophrenia drug Abilify (aripiprazole), from generics company Sandoz. The agency has also approved a generic version of Amgen’s treatment for high calcium levels Mimpara (cinacalcet) from Mylan, one generic version of GlaxoSmithKline’s heart-attack prevention Intergrilin (eptifibatide) from Accord Healthcare, one for a generic version of AbbVie’s HIV treatment Kaletra (lopinavir/ritonavir) from Mylan and five for generics of Eli Lilly’s carcinoma drug Alimta (pemetrexed) from Accord Healthcare, Actavis, Hospira, Medac and Sandoz.

Generics applications under review by EMA – August 2015

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 5]. 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 2016 Feb 5] Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU

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Source: EMA