Generics applications under review by EMA – July 2020 Posted 17/07/2020

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.

Related articles
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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