Generics applications under review by EMA

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Generics applications under review by EMA – August 2014

Genéricos/General | Posted 19/09/2014 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 8 September 2014, the agency is currently reviewing 21 applications for marketing approval in the EU for generics. The applications include one for blockbuster blood-clot treatment clopidogrel (Bristol-Myers Squibb/Sanofi’s Plavix), one for anti-fungal medication voriconazole (Pfizer’s Vfend) and 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
Aripiprazole	Psycoleptics (schizophrenia)	5	Abilify	Otsuka Pharmaceutical
Bortezomib	Antineoplastic (multiple myeloma)	1	Velcade	Janssen-Cilag
Budesonide/ formoterol	Obstructive airway diseases	3	Symbicort	AstraZeneca
Busulfan	Haematopoietic stem cell transplantation	1	Busulfex/Busilvex	Otsuka Pharmaceutical
Clopidogrel	Antithrombotic medicines	1	Plavix	Bristol-Myers Squibb/Sanofi
Docetaxel	Antineoplastic medicines	1	Taxotere	Aventis
Pregabalin	Antiepileptics	6	Lyrica	Pfizer
Sufentanil	Anaesthetics	1	Sufenta	Janssen Pharmaceutica
Tadalafil	Urologicals	1	Cialis	Eli Lilly
Voriconazole	Antimycotic	1	Vfend	Pfizer
Total		21
*Data collected on 16 September 2014. Source: EMA

On 18 July 2014, a tacrolimus generic (Envarsus), produced by Chiesi Farmaceutici received marketing authorization for the EU. The generic drug is indicated for the prevention of organ rejection. There are now three different tacrolimus drugs (including the originator Advagraf/Modigraf) approved by EMA for use in the EU to prevent organ rejection. The brand-name drug Protopic (tacrolimus) is also approved by EMA for use in the EU to treat atopic dermatitis (eczema).

First-time European generics under review by EMA include five for generics of Otsuka Pharmaceutical’s schizophrenia drug Abilify (Aripiprazole), one for a generic version of Janssen-Cilag’s multiple myeloma treatment Velcade (bortezomib), three for generic versions of AstraZeneca’s chronic obstructive pulmonary disease treatment Symbicort (budesonide/formoterol), one for a generic version of Otsuka Pharmaceutical’s stem cell transplantation drug Busulfex (busulfan), six for a generic version of Pfizer’s epilepsy treatment Lyrica (pregabalin), one for a generic version of Janssen Pharmaceutica’s potent opioid anaesthetic Sufenta (sufentanil) and one for a generic version of Eli Lilly’s erectile dysfunction drug Cialis (tadalafil).

Generics applications under review by EMA – April 2014

Clopidogrel goes off-patent: last of the old-style blockbusters

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 19]. 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 Sep 19] Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU

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Source: EMA