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*

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.

Related articles
Biosimilars applications under review by EMA – August 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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