Generics applications under review by EMA

Generics applications under review by EMA – December 2014

Generics/General | Posted 23/01/2015 post-comment

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 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).

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: EMA