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Generics applications under review by EMA – January 2021 Posted 22/01/2021

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 7 January 2021, the agency is currently reviewing 25 applications for marketing approval in the EU for generics.

The applications include six for antineoplastic (anticancer) medicines (dasatinib, doxorubicin, imatinib, and thiotepa); one for antithrombotic medicine rivaroxaban; one for a diagnostic medicine ioflupane (¹²³I); four for endocrine therapies (abiraterone and leuprorelin); two for immunosuppressants (azathioprine and fingolimod) and one for psycholeptic risperidone. There are already generics of these drugs 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)
Abiraterone	Endocrine therapy	3	Zytiga	Janssen-Cilag International
Azathioprine	Immunosuppressant	1	Azasan/Imuran/Imurel	–
Betaine	Alimentary tract and metabolism (homocystinuria)	1	Cystadane	Recordati Rare Diseases
Dabigatran	Antithrombotic medicine	1	Pradaxa	Boehringer Ingelheim
Dasatinib	Antineoplastic medicine (anticancer)	2	Sprycel	Bristol-Myers Squibb
Dexamethasone^#	Corticosteroid for systemic use (macular oedema/ uveitis and multiple myeloma)	1	Dexdor	Orion
Doxorubicin	Antineoplastic medicine (anticancer)	2	Caelyx/Myocet	Janssen-Cilag/ Teva Pharmaceutical Industries
Fingolimod	Immunosuppressant (multiple sclerosis)	1	Gilenya	Novartis
Icatibant	Haematological medicine (hereditary angioedema)	1	Firazyr	Shire Pharmaceuticals
Imatinib	Antineoplastic medicine (anticancer)	1	Glivec	Novartis
Ioflupane (¹²³I)	Diagnostic radiopharmaceutical	1	DaTscan	GE Healthcare
Leuprorelin	Endocrine therapy	1	–	–
Metformin/ sitagliptin	Diabetes	1	Efficib/Janumet/Ristfor/Velmetia	Merck Sharp and Dohme
Risperidone	Psycholeptic	1	–	–
Rivaroxaban	Antithrombotic medicine	1	Xarelto	Bayer
Sildenafil	Urological	1	Viagra Revatio	Pfizer Upjohn
Sitagliptin	Diabetes	2	Januvia/Ristaben/Tesavel/ Xelevia	Merck Sharp and Dohme
Sugammadex	Therapeutic medicine (reversal of anaesthesia)	1	Bridion	Merck Sharp and Dohme
Thiotepa	Antineoplastic medicine (anticancer)	1	Tepadina	Adienne
Vildagliptin/ metformin	Diabetes	1	Eucreas/Icandra/Zomarist	Novartis
Total		25
*Data collected on 12 January 2021. ^#Accelerated timetable for COVID-19-related medicine. Source: EMA.

First-time pan-European generics under review by EMA include one for a generic version of Cystadane (betaine) for the treatment of Homocystinuria (a rare inherited disorder of the amino acid methionine); one for a generic version of anticoagulant Pradaxa (dabigatran); one for a generic version of corticosteroid Dexdor (dexamethasone) for the treatment of COVID-19 patients; one for a generic version of Firazyr (icatibant) for the treatment of hereditary angioedema (a disorder that causes severe swelling); one for generic version of urological drug Viagra/Revatio (sildenafil); one for a generic version of anaesthesia reversal medicine Bridion (sugammadex) and five for generic versions of diabetes medicines (sitagliptin, metformin/sitagliptin and vildagliptin/metformin).

Since the last report entitled Generics applications under review by EMA – July 2020 by GaBI Online, EMA has approved one generic version of psycholeptic aripiprazole; four generic anticancer medications (arsenic trioxide, erlotinib, melphalan and sunitinib); one generic version of psychoanaleptic (caffeine citrate); one generic treatment for multiple sclerosis (fampridine); one generic immunosuppressant drug (lenalidomide); one generic endocrine therapy (leuprorelin); one generic diagnostic medicine (methylthioninium chloride) and one generic antithrombotic medicine (rivaroxaban).

EMA’s CHMP recommended approval of arsenic trioxide medac for the treatment of acute promyelocytic leukaemia (blood cancer) and fampridine Accord for the treatment of multiple sclerosis in July 2020 [3].

Lenalidomide Mylan was approved by EMA’s CHMP for the treatment of multiple myeloma and follicular lymphoma in November 2020 [4].

Generics applications under review by EMA – July 2020

LATIN AMERICAN FORUM – Coming soon! To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America. Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM – Próximamente! Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica. Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 22]. 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 2022 Jan 22]. Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval for arsenic trioxide and fampridine generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 22]. Available from: www.gabionline.net/Generics/News/EMA-recommends-approval-for-arsenic-trioxide-and-fampridine-generics
4. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of Lenalidomide Mylan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 22]. Available from: www.gabionline.net/Generics/News/EMA-recommends-approval-of-Lenalidomide-Mylan

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Source: EMA

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