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 2021, the agency is currently reviewing 26 applications for marketing approval in the EU for generics.

The applications include five for anti-neoplastic (anti-cancer) medicines (dasatinib, doxorubicin and imatinib); two for endocrine therapy leuprorelin; one for psycholeptic risperidone; one for anti-thrombic medicine rivaroxaban and one for multiple myeloma treatment thalidomide. 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)
Amifampridine	Potassium channel blocker (LEMS)	1	Firdapse (previously Zenas)	SERB
Betaine	Alimentary tract and metabolism (homocystinuria)	1	Cystadane	Recordati Rare Diseases
Dabigatran	Anti-thrombotic medicine	1	Pradaxa	Boehringer Ingelheim
Dasatinib	Anti-neoplastic medicine (anti-cancer)	2	Sprycel	Bristol-Myers Squibb
Dimethyl fumarate	Immunosuppressant (multiple sclerosis)	2	Tecfidera	Biogen
Doxorubicin	Anti-neoplastic medicine (anti-cancer)	2	Caelyx/Myocet	Janssen-Cilag/ Teva Pharmaceutical Industries
Ertapenem	Antibacterial	1	Invanz	Merck Sharp and Dohme
Ganirelix	Pituitary and hypothalamic hormones and analogues	1	Orgalutran	Organon
Imatinib	Anti-neoplastic medicine (anti-cancer)	1	Glivec	Novartis
Leuprorelin	Endocrine therapy	1	–	–
Metformin/ sitagliptin	Diabetes	2	Efficib/Janumet/ Ristfor/Velmetia	Merck Sharp and Dohme
Pirfenidone	Immunosuppressant (Idiopathic Pulmonary Fibrosis)	1	Esbriet	Roche
Risperidone	Psycholeptic	1	–	–
Rivaroxaban	Anti-thrombotic medicine	1	Xarelto	Bayer
Sapropterin	Metabolism products (HPA)	1	Kuvan	BioMarin International
Sildenafil	Urological	1	Viagra Revatio	Pfizer Upjohn
Sitagliptin	Diabetes	2	Januvia/Ristaben/ Tesavel/Xelevia	Merck Sharp and Dohme
Sugammadex	Therapeutic medicine (reversal of anaesthesia)	2	Bridion	Merck Sharp and Dohme
Thalidomide	Immunosuppressant (multiple myeloma)	1	-	-
Vildagliptin/ metformin	Diabetes	1	Eucreas/Icandra/ Zomarist	Novartis
Total		26
^*Data collected on 23 July 2021. HPA: hyperphenylalaninemia; LEMS: Lambert-Eaton Myasthenic Syndrome Source: EMA.

First-time pan-European generics under review by EMA include one for a generic version of Firdapse (amifampridine) for the treatment of Lambert-Eaton Myasthenic Syndrome; 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 anti-coagulant Pradaxa (dabigatran); two for generic versions of multiple sclerosis treatment Tecfidera (dimethyl fumarate); one for a generic version of antibacterial Invanz (ertapenem); one for a generic version of hormone treatment Orgalutran (ganirelix); one for a generic version of Idiopathic Pulmonary Fibrosis treatment Esbriet (pirfenidone); one for a generic version of hyperphenylalaninemia treatment Kuvan (sapropterin); 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 – January 2021 by GaBI Online, EMA has approved one generic version of endocrine therapy abiraterone; one generic version of psycholeptic aripiprazole; one generic version of corticosteroid dexamethasone for the treatment of COVID-19 patients; one generic version of icatibant for the treatment of hereditary angioedema (a disorder that causes severe swelling); one for a diagnostic medicine ioflupane (123I); one generic of immunosuppressant fingolimod; and one for anti-neoplastic (anti-cancer) medicine thiotepa.

Generics of anticancer medications abiraterone and thiotepa were approved by the EMA’s CHMP in January and February 2021 [1].

The EMA’s CHMP also recommended approval of abiraterone and ioflupane (123I) generics at its April 2021 meeting [2].

LATIN AMERICAN FORUM The brand-new section the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View this week’s headline article: ¿Qué conduce a las percepciones negativas de los biosimilares? Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de esta semana: ¿Qué conduce a las percepciones negativas de los biosimilares? Explore las noticias en el Foro Latinoamericano! 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 Jul 23]. 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 2021 Jul 23]. Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU

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Source: EMA