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 27 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 the EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use (CHMP) released on 8 June 2020, the agency is currently reviewing 25 applications for marketing approval in the EU for generics.

The generic drugs applications include nine for antineoplastic medicines (arsenic trioxide, dasatinib, doxorubicin, erlotinib, melphalan, sunitinib and thiotepa); one for antithrombotic medicine (rivaroxaban); two for diagnostic medicines (methylthioninium chloride and ioflupane (1231)); two for endocrine therapy (abiraterone and leuprorelin); two for Immunosuppressant (azathioprine and lenalidomide); one for diabetes sitagliptin; one for psychoanaleptic (caffeine citrate); two for psycholeptic (aripiprazole and risperidone) and one for urological drug (sildenafil), see Table 1.

Table 1: Generics under review by EMA*
Common name	Therapeutic area	Number of applications	EMA approved originator(s)	Originator company(ies)
Abiraterone	Endocrine therapy	2	Zytiga	Janssen-Cilag International
Aripiprazole	Psycholeptic	1	Abilify	Otsuka Pharmaceuticals
Arsenic trioxide	Antineoplastic medicine (anticancer medicine)	1	Trisenox	Teva
Azathioprine	Immunosuppressant	1	Azasan/Imuran/Imurel	–
Caffeine citrate	Psychoanaleptic	1	Peyona	Chiesi Farmaceutici
Dasatinib	Antineoplastic medicine (anticancer medicine)	2	Sprycel	Bristol-Myers Squibb
Doxorubicin	Antineoplastic medicine (anticancer medicine)	2	Myocet liposomal (previously Myocet)	Teva
Erlotinib	Antineoplastic medicine (anticancer medicine)	1	Tarceva	Roche
Fampridine	Other nervous system medicine (multiple sclerosis)	1	Fampyra	Biogen
Ioflupane (1231)	Diagnostic radiopharmaceuticals	1	DaTSCAN	GE Healthcare
Lenalidomide	Immunosuppressant	2	Revlimid	Celgene Europe
Leuprorelin	Endocrine therapy	1	–	–
Melphalan	Antineoplastic medicine (anticancer medicine)	1	Alkeran	ApoPharma
Methylthioninium chloride	Diagnostic medicines	1	Methylthioninium chloride Proveblue	Provepharm
Risperidone	Psycholeptic	1	–	–
Rivaroxaban	Antithrombotic medicine	1	Xarelto	Bayer
Sildenafil	Urological	1	Viagra Revatio	Pfizer Upjohn
Sitagliptin	Medicines used in diabetes	1	Januvia Tesavel Xelevia Ristaben	Merck Merck Merck Merck
Sugammadex	Other therapeutic medicines (reversal of anaesthesia)	1	Bridion	Merck
Sunitinib	Antineoplastic medicine (anticancer medicine)	1	Sutent	Pfizer
Thiotepa	Antineoplastic medicine (anticancer medicine)	1	Tepadina	Adienne
Total		25
*Data collected on 30 June 2020. Source: EMA.

First-time pan-European generics under review by EMA include one for endocrine therapy (leuprorelin), one for generic version of Pfizer’s urological drug Viagra/Upjohan’s Revatio (sildenafil); one for generic version of Merck’s diabetes medicines Januvia/Tesavel/Xelevia/Risaben (sitagliptin), one for generic version of Merck’s reversal of anaesthesia therapeutic medicines Bridion (sugammadex); and one for generic version of Adienne’s chemotherapy drug Thiotepa (tepadina).

Since the last report entitled Generics applications under review by EMA – January 2020 by GaBI Online, the CHMP has recommended five new generics [3, 4], including two of the anticancer medication azacytidine, one of arsenic trioxide, also an anticancer medication, one of cinacalcet, for the treatment of thyroid disorders, and one of the anticoagulant apixaban.

Generics applications under review by EMA – January 2020

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 17]. 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 2020 Jul 17]. Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends four new generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 17]. Available from: www.gabionline.net/Generics/News/EMA-recommends-four-new-generics
4. GaBI Online - Generics and Biosimilars Initiative. Generics of apixaban and chlorzoxazone approved in EU and US EU [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 17]. Available from: www.gabionline.net/Generics/News/Generics-of-apixaban-and-chlorzoxazone-approved-in-EU-and-US

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