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*

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), 

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Biosimilars applications under review by EMA – December 2016

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

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