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Generics applications under review by EMA – December 2014 Posted 23/01/2015

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 (CHMP) released on 6 January 2015, the agency is currently reviewing 25 applications for marketing approval in the EU for generics. The applications include one for anti-fungal medication voriconazole (Pfizer’s Vfend), 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

Psycoleptic (schizophrenia)

5

Abilify

Otsuka Pharmaceutical

Bortezomib

Antineoplastic (multiple myeloma)

1

Velcade

Janssen-Cilag

Docetaxel

Antineoplastic (chemotherapy)

1

Taxotere

Aventis

Duloxetine

Psychoanaleptic (anxiety, depression)

3

Cymbalta

Eli Lilly

Eptifibatide

Antithrombotic (blood-clot prevention)

1

Integrilin

GlaxoSmithKline

Pemetrexed

Antineoplastic (carcinoma, lung mesothelioma)

6

Alimta

Eli Lilly

Pregabalin

Antiepileptics

6

Lyrica

Pfizer

Sufentanil

Anaesthetics

1

Sufenta

Janssen Pharmaceutica

Voriconazole

Antimycotic

1

Vfend

Pfizer

Total

 

25

 

 

*Data collected on 22 January 2015
Source: EMA

On 19 November 2014, Teva Pharmaceutical Industries received marketing authorization in the EU for its generic version of AstraZeneca’s chronic obstructive pulmonary disease treatment Symbicort (budesonide/formoterol. Symbicort’s combination patent expired in the EU in 2012 and is due to expire in the US later in 2014, although AstraZeneca claims it has formulation patents valid until 2018 in the EU and 2023 in the US [3].

Fresenius Kabi, the generics arm of the Fresenius Healthcare Group, received EU marketing approval for its generic version of Otsuka Pharmaceutical’s stem cell transplantation drug Busulfex (busulfan) on 22 September 2014. While generics giant Mylan received EU approval for its generic version of Eli Lilly’s erectile dysfunction drug Cialis (tadalafil) on 21 November 2014.

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 generics of Eli Lilly’s anxiety/depression treatment Cymbalta (duloxetine), one for a generic version of GlaxoSmithKline’s heart attack prevention Intergrilin (eptifibatide), six for generics of Eli Lilly’s carcinoma drug Alimta (pemetrexed), six for generics of Pfizer’s epilepsy treatment Lyrica (pregabalin) and one for a generic version of Janssen Pharmaceutica’s potent opioid anaesthetic Sufenta (sufentanil).

Related articles
Biosimilars applications under review by EMA – December 2014

Generics applications under review by EMA – August 2014

References
1.   GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 23]. 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 2015 Jan 23]. Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU  
3.   GaBI Online - Generics and Biosimilars Initiative. Teva wins another Symbicort patent challenge [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 23]. Available from: www.gabionline.net/Generics/News/Teva-wins-another-Symbicort-patent-challenge 

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Source: EMA

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