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Generics applications under review by EMA – July 2019 Posted 02/08/2019

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 9 July 2019, the agency is currently reviewing 24 applications for marketing approval in the EU for generics. The applications include one for a generic version of Otsuka Pharmaceutical’s schizophrenia drug Abilify (aripiprazole), one for a generic version of Janssen-Cilag’s multiple myeloma treatment Velcade (bortezomib), one for Amgen’s hyperparathyroidism treatment Mimpara/Sensipar (cinacalcet), one for Bristol-Myers Squibb/Sanofi’s blood-clot treatment DuoPlavin (clopidogrel/ acetylsalicylic acid) and one for a generic version of Pfizer’s bacterial infection treatment Tygacil (tigecycline), for which there are already generics approved by EMA for all EU countries, see Table 1.

Table 1: Generics under review by EMA*

Common name

Therapeutic area

Number of applications

EMA approved originator(s)

Originator company(ies)

Apixaban

Anti-thrombotic medicine (anti-blood clot)

1

Eliquis

Bristol-Myers Squibb

Aripiprazole

Psycoleptic (schizophrenia)

1

Abilify

Otsuka Pharmaceutical

Arsenic trioxide

Anti-neoplastic medicine (anti-cancer)

2

Trisenox

Teva Pharmaceutical Industries

Azacitidine

Anti-neoplastic medicines (anti-cancer)

3

Vidaza

Celgene (Pharmion Corporation)

Bortezomib

Anti-neoplastic medicines (anti-cancer)

1

Velcade

Janssen-Cilag

Cabazitaxel

Anti-neoplastic medicines (anti-cancer)

1

Jevtana

sanofi-aventis

Cinacalcet

Calcium homeostasis

1

Mimpara/Sensipar

Amgen

Clofarabine

Anti-neoplastic medicines (anti-cancer)

1

Evoltra

Genzyme

Clopidogrel/ acetylsalicylic acid

Anti-thrombotic medicines (anti-blood clot)

1

DuoPlavin

Bristol-Myers Squibb/Sanofi

Dasatinib

Antineoplastic medicines (anticancer)

1

Sprycel

Bristol-Myers Squibb

Deferasirox

Other therapeutic medicines (iron chelator)

2

Exjade

Novartis

Dexmedetomidine

Psycholeptic (sedative)

1

Dexdor

Orion

Doxorubicin

Antineoplastic medicines (anticancer)

2

Caelyx/Myocet

Janssen-Cilag/ Teva Pharmaceutical Industries

Erlotinib

Antineoplastic medicines (anticancer)

1

Tarceva

Roche

Fingolimod

Immunosuppressant (multiple sclerosis)

2

Gilenya

Novartis

Melphalan

Antineoplastic medicines (anticancer)

1

Alkeran

ApoPharma

Methylthioninium chloride

Diagnostic medicine

1

Proveblue

Provepharm SAS

Tigecycline

Antibacterials for systemic use

1

Tygacil

Pfizer

Total

 

24

 

 

*Data collected on 26 July 2019.

Source: EMA.

First-time pan-European generics under review by EMA include one for a generic version of Bristol-Myers Squibb’s blood clot preventer Eliquis (apixaban), two for generics of Teva’s leukaemia drug Trisenox (arsenic trioxide), three for generics of Celgene’s treatment for myelodysplastic syndrome Vidaza (azacitidine), one for a generic version of Janssen-Cilag’s prostate cancer drug Jevtana (cabazitaxel), one for a generic version of leukaemia medicine Evoltra (clofarabine), one for a generic version of Bristol-Myers Squibb’s leukaemia drug Sprycel (dasatinib), two for generic versions of iron chelator Exjade (deferasirox) from Novartis, one for a generic version of Orion’s psycholeptic Dexdor (dexmedetomidine), two for generic versions of Janssen-Cilag/Teva’s chemotherapy drug Caelyx/Myocet (doxorubicin), one for a generic version of Roche’s Tarceva (erlotinib), one for a generic version of multiple sclerosis drug Gilenya (fingolimod) from Novartis, one for a generic version of chemotherapy drug Alkeran (melphalan) and one for a generic version of ProvePharma’s methaemoglobinaemia treatment Proveblue (methylthioninium chloride).

Since the last report entitled Generics applications under review by EMA – January 2019 by GaBI Online, EMA has approved two generic versions of Glaxo’s pulmonary hypertension drug Volibris (ambrisentan), one generic version of HIV drug Reyataz (atazanavir), one generic version of gout treatment Adenuric (febuxostat), one for a generic version of Addmedica’s leukaemia and cervical cancer drug Siklos (hydroxycarbamide), one for a generic version of GE Healthcare’s neuroimaging drug DaTSCAN (ioflupane (123l), one for a generic version of Celgene’s chemotherapy drug Abraxane (paclitaxel) and one for a generic version of MSD’s fungus treatment Noxafil (posaconazole).

Ambrisentan Mylan (ambrisentan) was approved by EMA’s CHMP for the treatment of pulmonary arterial hypertension and Striascan [ioflupane (123I)], a radiopharmaceutical was approved for the diagnosis of Parkinson’s disease and other related diseases and dementia in April 2019 [1].

On 29 May 2019, EMA’s CHMP adopted a positive opinion, recommending the granting of a marketing authorization for two new generics for the treatment and prevention of fungal infections, Posaconazole Accord and Posaconazole AHCL [2].

Related article
Generics applications under review by EMA – January 2019

References
1. GaBI Online - Generics and Biosimilars Initiative. EMA approves hypertension and Parkinson’s generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 2]. Available from: www.gabionline.net/Generics/News/EMA-approves-hypertension-and-Parkinson-s-generics 
2. GaBI Online - Generics and Biosimilars Initiative. EMA approves two generics for fungal infections [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 2]. Available from: www.gabionline.net/Generics/News/EMA-approves-two-generics-for-fungal-infections 

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Source: EMA

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