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Generics applications under review by EMA – 2013 Q4 Posted 10/01/2014

Last update:  20 January 2014

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 released on 5 December 2013, the agency is currently reviewing six applications for marketing approval in the EU for generics. The applications include one for dementia treatment rivastigmine, for which there are already generics approved by EMA, see Table 1.

First-time European generics under review by EMA include one for a generic version of AstraZeneca’s chronic obstructive pulmonary disease treatment Symbicort (budesonide/formoterol), one for a generic version of Otsuka Pharmaceutical’s Busulfex (busulfan), one for Roche’s flu treatment Tamiflu (oseltamivir), one for a generic version of Advagraf/Modigraf (tacrolimus), made by Astellas; and one for a generic version of bone cancer treatment Aclasta/Zometa (zoledronic acid), made by Novartis.

Table 1: Generics under review by EMA*

Common name

Therapeutic area

Number of applications

Originator product

Originator company

Budesonide/
formoterol

Obstructive airway diseases

1

Symbicort

AstraZeneca

Busulfan

Haematopoietic stem cell transplantation

1

Busulfex/Busilvex

Otsuka Pharmaceutical

Oseltamivir

Antiviral
(flu treatment)

1

Tamiflu

Genentech (Roche)

Rivastigmine

Psychoanaleptic
(Alzheimer’s & Parkinson’s disease)

1

Exelon

Novartis

Tacrolimus

Immunosuppressant
(organ rejection)

1

Advagraf/Modigraf

Astellas

Zoledronic acid

Bone disease

1

Aclasta/Zometa

Novartis

Total

 

6

 

 

*Data collected on 7 January 2014.
Source: EMA

On 4 December 2013, a Memantine generic, Memantine Accord, produced by Accord Healthcare received marketing authorization for the EU. The generic drug is indicated for the treatment of patients with moderate to severe Alzheimer’s disease. There are now 11 different memantine drugs including the originator Axura approved by EMA for the EU.

Since the last report by GaBI Online for 2013 Q3, EMA has removed generic levetiracetam and a generic zoledronic acid from its list. However, no marketing authorizations have appeared on the agency’s website, leading GaBI Online to believe that these applications have been withdrawn.

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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 2014 Jan 10]. 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 2014 Jan 10]. Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU

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Source: EMA

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