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Generics applications under review by EMA – January 2022

Generics/General | Posted 28/01/2022 0 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 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 4 January 2022, the agency is currently reviewing 35 applications for marketing approval in the EU for generics.

The applications include four for anti-neoplastic (anticancer) medicines (masitinib, doxorubicin); one for endocrine therapy leuprorelin; one for Gaucher disease treatment Yargesa (miglustat), one for a generic version of Alimta (pemetrexed), one for a generic version of diabetes medicine Efficib/Janumet/Velmetia (sitagliptin/metformin 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
Budesonide	Anti-diarrheal, intestinal anti‑inflammatory/ anti‑infective agent	1	Jorveza	Dr Falk Pharma
Dabigatran	Anti-thrombotic medicine	1	Pradaxa	Boehringer Ingelheim
Dasatinib	Anti-neoplastic medicine (anticancer)	2	Sprycel	Bristol-Myers Squibb
Dimethyl fumarate	Immunosuppressant (multiple sclerosis)	6	Tecfidera	Biogen
Doxorubicin	Anti-neoplastic medicine (anticancer)	2	Caelyx/Myocet	Janssen-Cilag/ Teva Pharmaceutical Industries
Ertapenem	Anti‑bacterial	1	Invanz	Merck Sharp and Dohme
Ganirelix	Pituitary and hypothalamic hormones and analogues	1	Orgalutran	Organon
Leuprorelin	Endocrine therapy	1	–	–
Miglustat	Other alimentary tract and metabolism products (Gaucher disease)	1	Zavesca	Actelion
Octreotide acetate	Pituitary and hypothalamic hormones and analogues	1	–	–
Pemetrexed	Antineoplastic medicine (anticancer)	1	Alimta	Eli Lilly
Pirfenidone	Immunosuppressant (Idiopathic Pulmonary Fibrosis)	2	Esbriet	Roche
Plerixafor	Immunostimulant (multiple myeloma/ haematopoietic stem cell transplantation/ lymphoma)	1	Mozobil	Genzyme
Sirolimus	Immunosuppressant (graft rejection/ kidney transplantation)	1	Rapamune	Pfizer
Sitagliptin	Diabetes	1	Januvia/Ristaben/ Tesavel/Xelevia	Merck Sharp and Dohme
Sitagliptin/ metaformin	Diabetes	1	Efficib/Janumet/ Ristfor/Velmetia	Merck Sharp and Dohme
Sorafenib	Anti‑neoplastic medicine (hepatocellular and renal cell carcinoma)	1	Nexavar	Bayer
Spironolactone	Diuretic (heart failure)	1	Aldactone	Pfizer
Sugammadex	Therapeutic medicine (reversal of anaesthesia)	2	Bridion	Merck Sharp and Dohme
Teriflunomide	Immunosuppressant (multiple sclerosis)	2	Aubagio	sanofi-aventis
Thalidomide	Immunosuppressant (multiple myeloma)	1	-	-
Tolvaptan	Diuretic (low blood sodium levels)	1	Jinarc/Samsca	Otsuka Pharmaceutical
Vildagliptin/ metformin	Diabetes	1	Eucreas/Icandra/ Zomarist	Novartis
Total		35

*Data collected on 18 January 2022.
HPA: hyperphenylalaninaemia; 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 (LEMS); 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 Crohn's disease treatment Jorveza (budesonide); one for a generic version of anti-coagulant Pradaxa (dabigatran); six for generic versions of multiple sclerosis treatment Tecfidera (dimethyl fumarate); one for a generic version of antibacterial Invanz (ertapenem); two for generic versions of hormone treatments Orgalutran (ganirelix) and octreotide acetate; two for generic versions of Idiopathic Pulmonary Fibrosis treatment Esbriet (pirfenidone); one for a generic version of multiple myeloma treatment Mozobil (plerixafor); one for a generic version of Rapamune (sirolimus), which is used for the prophylaxis of organ rejection; one for a generic version of renal cell carcinoma treatment Nexavar (sorafenib); one for a generic version of heart failure treatment Aldactone (spironolactone); two for generic versions of anaesthesia reversal medicine Bridion (sugammadex); two for generic versions of multiple sclerosis treatment Aubagio (teriflunomide); one for a generic version of diuretic Jinarc/Samsca (tolvaptan) and two for generic versions of diabetes medicines (sitagliptin and vildagliptin/ metformin).

Since the last report entitled Generics applications under review by EMA – July 2021 by GaBI Online, EMA has approved one generic version of anti-neoplastic (anticancer) medicine imatinib; two for generic versions of diabetes medicines metformin/ sitagliptin; one generic version of psycholeptic risperidone; one generic version of anti-thrombic medicine rivaroxaban; one generic version of hyperphenylalaninaemia treatment sapropterin; one generic version of urological drug sildenafil and one generic version of diabetes medicine sitagliptin/metformin.

Generics applications under review by EMA – July 2021

LATIN AMERICAN FORUM The new section of 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: Diferencias en inmunogenicidad, farmacovigilancia y documentos legales en productos biológicos en América Latina 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: Diferencias en inmunogenicidad, farmacovigilancia y documentos legales en productos biológicos en América Latina Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. 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 2022 Jan 28]. 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 28]. Available from: www.gabionline.net/reports/Registration-procedures-for-generic-drugs-in-the-EU

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Source: EMA