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Generics applications under review by EMA – 2012 Q4

Generics/General | Posted 18/01/2013 0 Post your comment

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 December 2012 the agency is currently reviewing 17 applications for marketing approval in the EU for generics. The applications include one for atosiban, one for capecitabine, one for esomeprazole, three for imatinib, seven for memantine, one for telmisartin, and 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 one for a generic version of 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
Atosiban	Gynaecologicals (premature labour preventative)	1	Tractocile/ Antocin	Ferring Pharmaceuticals/ Johnson & Johnson
Capecitabine	Antineoplastic medicines (cancer)	1	Xeloda	Roche
Esomeprazole	Acid-related disorders	1	Nexium	AstraZeneca
Imatinib	Antineoplastic medicine (cancer)	3	Glivec	Novartis
Memantine	Psychoanaleptic (Alzheimer’s disease)	7	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	1	Aclasta/Zometa	Novartis
Total		17
*Data collected on 10 January 2013 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.

On 16 January 2013, Teva gains approval to market generic imatinib in Europe.

The fact that there are no less than seven generics applications under review for the Alzheimer’s disease treatment memantine just goes to show the increased interest of pharma in dementia. In fact, September 2012 was World Alzheimer’s Month, with the theme ‘Dementia: Living together’.

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References

1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jan 18]. 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 2013 Jan 18]. Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU

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Source: EMA, Teva