Generics applications under review by EMA – July 2020

Genéricos/General | Posted 17/07/2020 post-comment0 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 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].

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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.

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Biosimilars applications under review by EMA – July 2020

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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