Generics applications under review by EMA

Generics applications under review by EMA – April 2015

Genéricos/General | Posted 05/06/2015 post-comment

0 Post your comment

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 7 April 2015, the agency is currently reviewing 34 applications for marketing approval in the EU for generics. The applications include 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.

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 7 April 2015, the agency is currently reviewing 34 applications for marketing approval in the EU for generics. The applications include one for anti-fungal medication voriconazole (Pfizer’s Vfend), one for chemotherapy drug docetaxel (Taxotere – made by Aventis), for which there are already generics approved by EMA, 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)	5	Abilify	Otsuka Pharmaceutical
Atazanavir	Anti-retroviral (HIV treatment)	1	Reyataz	Bristol-Myers Squibb
Bortezomib	Antineoplastic (multiple myeloma)	2	Velcade	Janssen-Cilag
Caspofungin	Antimycotic (antifungal)	1	Cancidas	Merck
Cinacalcet	Calcium homeostasis	1	Mimpara	Amgen
Docetaxel	Antineoplastic (chemotherapy)	1	Taxotere	Sanofi
Duloxetine	Psychoanaleptic (anxiety, depression)	3	Cymbalta	Eli Lilly
Eptifibatide	Antithrombotic (blood-clot prevention)	1	Integrilin	GlaxoSmithKline
Lopinavir/ ritonavir	Anti-retroviral (HIV treatment)	1	Kaletra	AbbVie
Methotrexate	Antineoplastic (cancer, arthritis)	1	Maxtrex	Pfizer
Miglustat	Metabolism (Gaucher disease)	1	Zavesca	Actelion
Pemetrexed	Antineoplastic (carcinoma, lung mesothelioma)	7	Alimta	Eli Lilly
Pregabalin	Antiepileptics	6	Lyrica	Pfizer
Rasagiline	Parkinson’s disease	1	Azilect	Teva Pharmaceutical Industries
Sufentanil	Anaesthetics	1	Sufenta	Janssen Pharmaceutica
Total		34
*Data collected on 4 June 2015. Source: EMA

First-time European generics under review by EMA include one for a generic version of high blood pressure treatment Exforge (amlodipine/valsartan), five for generics of Otsuka Pharmaceutical’s schizophrenia drug Abilify (aripiprazole), one for a generic version of Bristol-Myers Squibb’s anti-retroviral HIV treatment Reyataz (atazanavir), two for generic versions of Janssen-Cilag’s multiple myeloma treatment Velcade (bortezomib), 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), three for generics of Eli Lilly’s anxiety/depression treatment Cymbalta (duloxetine), one for a generic version of GlaxoSmithKline’s heart-attack prevention Intergrilin (eptifibatide), one for AbbVie’s HIV treatment Kaletra (lopinavir/ritonavir), one for a generic version of Actelion’s Gaucher disease treatment Zavesca (miglustat), seven for generics of Eli Lilly’s carcinoma drug Alimta (pemetrexed), six for generics of Pfizer’s epilepsy treatment Lyrica (pregabalin) and one for a generic version of Janssen Pharmaceutica’s potent opioid anaesthetic Sufenta (sufentanil).

Since the last report entitled ‘Generics applications under review by EMA – December 2014’ by GaBI Online, EMA has approved a generic version of Pfizer’s anti-fungal medication Vfend (voriconazole).

G enerics applications under review by EMA – December 2014

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 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 2015 Jun 5] Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: EMA