Generics applications under review by EMA

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 anti-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 Genzyme's 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 anticancer drug 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].

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