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Generics applications under review by EMA – April 2014

Generics/General | Posted 09/05/2014 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 (CHMP) for Human Use released on 25 April 2014, the agency is currently reviewing seven applications for marketing approval in the EU for generics. The applications include one for anti-fungal medication voriconazole (Pfizer’s Vfend), for which there are already generics approved by EMA, see Table 1.

First-time European generics under review by EMA include three for generic versions of AstraZeneca’s chronic obstructive pulmonary disease treatment Symbicort (budesonide/formoterol), one for a generic version of Otsuka Pharmaceutical’s Busulfex (busulfan), one for a generic version of Advagraf/Modigraf (tacrolimus), made by Astellas and one for a generic version of Eli Lilly’s erectile dysfunction drug Cialis (tadalafil).

Table 1: Generics under review by EMA*

Common name	Therapeutic area	Number of applications	Originator product	Originator company
Budesonide/ formoterol	Obstructive airway diseases	3	Symbicort	AstraZeneca
Busulfan	Haematopoietic stem cell transplantation	1	Busulfex/Busilvex	Otsuka Pharmaceutical
Tacrolimus	Immunosuppressant (organ rejection)	1	Advagraf/Modigraf	Astellas
Tadalafil	Urologicals	1	Cialis	Eli Lilly
Voriconazole	Antimycotic	1	Vfend	Pfizer
Total

*Data collected on 8 May 2014.
Source: EMA

On 20 March 2014, CHMP adopted a positive opinion, recommending the granting of a marketing authorization, for Ebilfumin (oseltamivir), produced by Actavis. The drug is a generic of Roche’s flu treatment Tamiflu.

On 3 April 2014, a rivastigmine generic, produced by 3M Health Care received marketing authorization for the European Union (EU). The generic drug is indicated for the treatment of patients with Alzheimer’s disease. There are now nine different rivastigmine drugs (including the originator Exelon) approved by EMA for use in the EU.

Teva Generics also received approval for its zoledronic acid generic on 27 March 2014. The generic drug is indicated for the treatment of patients with osteoporosis.

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1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 9]. 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 May 9]. Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU

Source: EMA