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 10 August 2015, the agency is currently reviewing 25 applications for marketing approval in the EU for generics. The applications include two for generics of Otsuka Pharmaceutical’s schizophrenia drug Abilify (aripiprazole), one for Janssen-Cilag’s multiple myeloma treatment Velcade (bortezomib), one for chemotherapy drug docetaxel (Taxotere, Sanofi), one 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
Amlodipine/valsartan	Renin-angiotensin (high blood pressure)	1	Exforge	Novartis
Aripiprazole	Psycoleptic (schizophrenia)	2	Abilify	Otsuka Pharmaceutical
Atazanavir	Anti-retroviral (HIV treatment)	1	Reyataz	Bristol-Myers Squibb
Bortezomib	Anti-neoplastic (multiple myeloma)	1	Velcade	Janssen-Cilag
Caspofungin	Antimycotic (antifungal)	1	Cancidas	Merck
Cinacalcet	Calcium homeostasis	1	Mimpara	Amgen
Docetaxel	Anti-neoplastic (chemotherapy)	1	Taxotere	Sanofi Aventis
Emtricitabine/tenofovir disoproxil	Anti-retroviral (HIV treatment)	1	Truvada	Gilead Sciences
Eptifibatide	Anti-thrombotic (blood-clot prevention)	1	Integrilin	GlaxoSmithKline
Fluticasone/salmeterol	Obstructive airway disease (asthma/COPD)	2	Advair/Seretide	GlaxoSmithKline
Lopinavir/ritonavir	Anti-retroviral (HIV treatment)	1	Kaletra	AbbVie
Methotrexate	Anti-neoplastic (cancer, arthritis)	1	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	Anti-neoplastic (carcinoma, lung mesothelioma)	6	Alimta	Eli Lilly
Rasagiline	Parkinson’s disease	1	Azilect	Teva Pharmaceutical Industries
Zonisamide	Anti-epileptic	1	Zonegran	Eisai
Total		25
*Data collected on 1 September 2015. COPD: chronic obstructive pulmonary disease. Source: EMA

First-time European generics under review by EMA include one for a generic version of high blood pressure treatment Exforge (amlodipine/valsartan), one for a generic version of Bristol-Myers Squibb’s anti-retroviral HIV treatment Reyataz (atazanavir), one for a generic version of Merck’s antifungal medication Cancidas (caspofungin), one for a generic version of Amgen’s treatment for high calcium levels Mimpara (cinacalcet), one for a generic version of Gilead Sciences HIV treatment Truvada (emtricitabine/tenofovir disoproxil), one for a generic version of GlaxoSmithKline’s heart-attack prevention Intergrilin (eptifibatide), one for GlaxoSmithKline’s asthma and chronic obstructive pulmonary disorder treatment Advair/Seretide (fluticasone/salmeterol), one for AbbVie’s HIV treatment Kaletra (lopinavir/ritonavir), 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), six for generics of Eli Lilly’s carcinoma drug Alimta (pemetrexed) and one for Eisai’s epilepsy treatment Zonegran (zonisamide).

Since the last report entitled ‘Generics applications under review by EMA – April 2015’ by GaBI Online, EMA has approved two generic versions of Otsuka Pharmaceutical’s schizophrenia drug Abilify (aripiprazole), from generics companies Pharmathen and Zentiva. The agency has also approved a generic version of Pfizer’s anti-fungal medication Vfend (voriconazole) from Accord Healthcare, two generics of Eli Lilly’s anxiety/depression treatment Cymbalta (duloxetine) from Mylan and Zentiva and five for generics of Pfizer’s epilepsy treatment Lyrica (pregabalin) from Mylan, Sandoz and Zentiva.

Generics of Eli Lilly’s carcinoma drug Alimta (pemetrexed) from Eli Lilly and Sandoz and a generic version of Janssen Pharmaceutica’s potent opioid anaesthetic Sufenta (sufentanil) from Grunenthal received a positive opinion from EMA’s CHMP on 23 July 2015.

Generics applications under review by EMA – April 2015

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 4]. 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 2015 Sep 4]. Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU

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Source: EMA