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 3 August 2016, the agency is currently reviewing 26 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),one for a generic version of Pfizer’s anti-epileptic Lyrica (pregabalin), one for a generic version of Pfizer’s erectile dysfunction drug Viagra (sildenafil) and one for a generic version of Eli Lilly’s erectile dysfunction drug Adcirca/Cialis (tadalafil) 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
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)	1	Atripla	Gilead Sciences/ Bristol-Myers Squibb
Emtricitabine/ tenofovir disoproxil	Anti-retroviral (HIV treatment)	3	Truvada	Gilead Sciences
Ertapenem	Anti-bacterial for systemic use	1	Invanz	Merck
Febuxostat	Anti-gout medicine	1	Adenuric	Ipsen/ TAP Pharmaceuticals
Ivabradine	Cardiac therapy (angina)	3	Corlanor/ Procoralan	Amgen/ Servier
Methotrexate	Anti-neoplastic (cancer, arthritis)	1	Maxtrex	Pfizer
Miglustat	Metabolism (Gaucher disease)	1	Zavesca	Actelion
Nitisinone	Hereditary tyrosinemia type 1	1	Orfadin	Swedish Orphan Biovitrum International
Pemetrexed	Anti-neoplastic (carcinoma, lung mesothelioma)	2	Alimta	Eli Lilly
Pregabalin	Anti-epileptic	1	Lyrica	Pfizer
Sildenafil	Erectile dysfunction	2	Viagra	Pfizer
Tadalafil	Erectile dysfunction	1	Adcirca/Cialis	Eli Lilly
Tenofovir disoproxil	Antiretroviral (HIV treatment)	1	Viread	Gilead Sciences
Teriparatide	Osteoporosis	2	Forsteo	Eli Lilly
Tigecycline	Antibacterial	1	Tygacil	Pfizer
Total		26
*Data collected on 2 September 2016 COPD: chronic obstructive pulmonary disease. Source: EMA

First-time European generics under review by EMA include 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), one for a generic version of Gilead Sciences HIV treatment Atripla (Efavirenz/ emtricitabine/ tenofovir disoproxil ), three for generic versions of Gilead Sciences HIV treatment Truvada (emtricitabine/tenofovir disoproxil), one for a generic version of Merck’s antibiotic Invanz (ertapenem), one for a generic version of TAP Pharmaceuticals/Ipsen’s gout treatment Adenuric (febuxostat), one for a generic version of Actelion’s Gaucher disease treatment Zavesca (miglustat), one for a generic version of Swedish Orphan Biovitrum International’s treatment for hereditary tyrosinemia type 1 Orfadin (nitisinone), two for generic versions of Eli Lilly’s carcinoma drug Alimta (pemetrexed), one for a generic of Gilead’s HIV treatment Viread (tenofovir disoproxil), two for generic versions of Eli Lilly’s osteoporosis treatment Forsteo (teriparatide) and one for a generic of Pfizer’s antibiotic Tygacil (tygecycline).

Since the last report entitled ‘Generics applications under review by EMA – April 2016’ by GaBI Online, EMA has approved one for a generic version of MSD’s osteoporosis treatment Fosavance/ Vantavo (alendronic acid/ colecalciferol), one for a generic version of Bristol-Myers Squibb’s HIV treatment Reyataz (atazanavir), two for generics of Janssen-Cilag’s multiple myeloma treatment Velcade (bortezomib), one for chemotherapy drug docetaxel (Taxotere, Sanofi), two for GlaxoSmithKline’s asthma and chronic obstructive pulmonary disorder treatment Advair/Seretide (fluticasone/salmeterol), one for a generic of Gilead’s HIV treatment Viread (tenofovir disoproxil)

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sept 16]. 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 Sept 16] Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU

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Source: EMA