Last update: 6 September 2013
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 27 EU member states and in Norway, Iceland and Liechtenstein. 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 released in September 2012 the agency is currently reviewing 18 applications for marketing approval in the EU for generics. The applications include two for capecitabine, one for esomeprazole, one for ibandronic acid, three for imatinib, six for memantine, one for telmisartin, one for telmisartan/hydrochlorothiazide, see Table 1.
First-time European generics under review by EMA include one for a generic version of Pfizer’s antimycotic Vfend (voriconazole) and two for Novartis’s bone cancer treatment Aclasta/Zometa (zoledronic acid).
Table 1: Generics under review by EMA*
| Generic name
|
Therapeutic area
|
Number of applications
|
Originator product
|
Originator company
|
| Capecitabine
|
Antineoplastic medicines (cancer)
|
2
|
Xeloda
|
Roche
|
| Esomeprazole
|
Acid-related disorders
|
1
|
Nexium
|
AstraZeneca
|
| Ibandronic acid
|
Bone disease
|
1
|
Bondronat
|
Roche
|
| Imatinib
|
Antineoplastic medicine (cancer)
|
3
|
Glivec
|
Novartis
|
| Memantine
|
Psychoanaleptic (Alzheimer’s disease)
|
6
|
Axura
|
Ely Lilly
Merz Pharmaceuticals
|
| Telmisartan
|
Reninangiotensin system (blood pressure treatment)
|
1
|
Pritor/Kinzal
|
Bayer
|
| Telmisartan / hydrochlorothiazide
|
Reninangiotensin system (blood pressure treatment)
|
1
|
-
|
-
|
| Voriconazole
|
Antimycotic
|
1
|
Vfend
|
Pfizer
|
| Zoledronic acid
|
Bone disease
|
2
|
Aclasta/Zometa
|
Novartis
|
| Total
|
|
18
|
|
|
*Data collected on 27 September 2012
Source: EMA
|
The patent for Novartis’s pioneering cancer drug Glivec (imatinib), on the other hand, only runs out in 2016 for Europe and in 2015 for the USA, this will give Novartis some time before competition from generics. The drug had worldwide sales in 2011 of US$1.51 billion.
The fact that there are six generics applications under review for Alzheimer’s disease treatment memantine shows the increased interest of pharma in dementia. In fact, September 2012 was World Alzheimer’s Month, with the theme ‘Dementia: Living together’.
Related article
EMA receives second application for biosimilar infliximab
References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 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 2012 Dec 4]. 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.
Copyright – Unless otherwise stated all contents of this website are © 2013 Pro Pharma Communications International. All Rights Reserved.
2
Post your comment